Research & Clinical Trials
Research & Clinical Trials
Clinical Trials
A clinical trial is a type of research that helps medical professionals learn about benefits and risks associated with promising new treatments or techniques. The ultimate goal of clinical trials is to improve the lives of patients and clinical trials may introduce therapies or technologies before they are available anywhere else.
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Evaluation of the Clinical Performance and Safety of an Investigational Fully Covered Biliary Stent with Anti-migration Flaps for the Palliative Treatment of Malignant Biliary Obstruction HANAROSTENT® Biliary Flap Lasso Stent System IDE Study +
Evaluation of the Clinical Performance and Safety of an Investigational Fully Covered Biliary Stent with Anti-migration Flaps for the Palliative Treatment of Malignant Biliary Obstruction HANAROSTENT® Biliary Flap Lasso Stent System IDE Study
Protocol No: 2021-GI-01
Age Group: Adult
Disease Sites: Biliary Obstruction
NCT Id: NCT05058261
Phase: N/A
Principal Investigators: Shyam Varadarajulu, MD
Eligibility Document -
Attachment Id: 18274
File Name: Olympus 2021-GI-01 Version 1.6 06Jun2025 - Subject Eligibility _Screening Checklist.docx
URL:
Objective
The study objective is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.
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Registry of Patients Undergoing Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Procedures Using the Slim Endoscopes +
Registry of Patients Undergoing Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Procedures Using the Slim Endoscopes
Protocol No: 22-151-07
Age Group: Adult
Disease Sites: Esophageal Disease
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Ji Bang, MD
Objective
The primary outcome measure is to evaluate the rate of successful completion of EUS and ERCP procedures using the slim linear ultrasound endoscope and slim duodenoscopes, in patients in whom endoscopic examination is unable to be completed using the standard endoscopes.
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Artificial Intelligence in Endoscopic Ultrasound +
Artificial Intelligence in Endoscopic Ultrasound
Protocol No: 24-015-01
Age Group: Adult
Disease Sites: Pancreatic Disease
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Shyam Varadarajulu, MD
Objective
Determine ability of AI system (Pancreas, Medical Soft verse) to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.
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Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound +
Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
Protocol No: 25-170-07
Disease Sites: Other
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Ji Bang, MD
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A Phase 2B, Multicenter, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects with Moderately to Severely Active Crohns Disease +
A Phase 2B, Multicenter, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects with Moderately to Severely Active Crohns Disease
Protocol No: ABX464-202
Age Group: Adult
Disease Sites: Crohn's Disease
NCT Id: NCT06456593
Phase: II
Principal Investigators: Udayakumar Navaneethan, MD
Eligibility Document -
Attachment Id: 15181
File Name: ABX464-202 Subject Eligibility _Screening Checklist Version 3 dated 21april2024.docx.docx
URL:
Objective
The primary objective for the Induction Phase is to evaluate the efficacy of obefazimod compared to placebo as induction therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
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Prospective Randomized Comparison of En Bloc Versus Piecemeal Resection of Barrett Neoplasms of Esophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection +
Prospective Randomized Comparison of En Bloc Versus Piecemeal Resection of Barrett Neoplasms of Esophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
Protocol No: BEEPER
Age Group: Adult
Disease Sites: Barrett's Esophagus
NCT Id: NCT03427346
Phase: N/A
Principal Investigators: Ji Bang, MD
Eligibility Document -
Attachment Id: 16396
File Name: BEEPER version 6.1 26Apr2025 - Subject Eligibility _Screening Checklist.pdf
URL:
Objective
This study is checking how well the treatment removes abnormal cells in the esophagus and keeps them from coming back, by doing follow-up exams at 3, 9, 24, and 33 months after treatment.
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Registry of Patients Undergoing Endoscopic Management of Bile Duct Stones +
Registry of Patients Undergoing Endoscopic Management of Bile Duct Stones
Protocol No: BILE-DUCT-STONES-REGISTRY
Age Group: Adult
Disease Sites: Bile Duct Stones
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Ji Bang, MD
Objective
The primary outcome measure is to evaluate the degree of adherence to the algorithmic approach to the management of bile duct stones.
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A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC) +
A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)
Protocol No: C5041047
Age Group: Adult
Disease Sites: Ulcerative Colitis
NCT Id: NCT06398626
Phase: N/A
Principal Investigators: Udayakumar Navaneethan, MD
Objective
To assess the real-world effectiveness of etrasimod on symptomatic remission at week 12
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Clinical and Histological Outcomes of Patients with Barrett's Esophagus Undergoing Endoscopic Submucosal Dissection +
Clinical and Histological Outcomes of Patients with Barrett's Esophagus Undergoing Endoscopic Submucosal Dissection
Protocol No: CLIN-AND-HISTO-OUTCOMES-ESD
Age Group: Adult
Disease Sites: Barrett's Esophagus
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Ji Bang, MD
Objective
This study aims to understand how well treatment works to fully remove abnormal cells in the esophagus, how safe the procedure is, how often the condition comes back, and what factors might predict a recurrence after successful treatment.
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Validation of COMPAT-SF Spanish Translation for Patients with Chronic Pancreatitis +
Validation of COMPAT-SF Spanish Translation for Patients with Chronic Pancreatitis
Protocol No: COMPAT-SF
Disease Sites: Other
NCT Id: NCT06698302
Phase: N/A
Principal Investigators: Charles Wilcox, MD
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Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope. +
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope.
Protocol No: ECHOENDO
Age Group: Adult
Disease Sites: Gastric Disease
NCT Id: NCT06340620
Phase: N/A
Principal Investigators: Ji Bang, MD
Eligibility Document -
Attachment Id: 16397
File Name: EchoEndo version 1 23Feb2024 Prescreening Eligibility Template.pdf
URL:
Objective
The primary aim of this randomized trial is to compare the rate of completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes.
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Randomized Trial of EUS-Guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis +
Randomized Trial of EUS-Guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
Protocol No: EPOCH
Age Group: Adult
Disease Sites: Pancreatic Disease
NCT Id: NCT06178315
Phase: N/A
Principal Investigators: Charles Wilcox, MD
Eligibility Document -
Attachment Id: 16417
File Name: EPOCH Version 2.0 17Mar2024 - Subject Eligibility _Screening Checklist.pdf
URL:
Objective
This study is looking at how well a procedure helps relieve pain in people with chronic pancreatitis, by checking if their pain is reduced by half one month after treatment.
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A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Ulcerative Colitis. +
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Ulcerative Colitis.
Protocol No: GA45329
Age Group: Both
Disease Sites: Ulcerative Colitis
NCT Id: NCT06589986
Phase: III
Principal Investigators: Udayakumar Navaneethan, MD
Eligibility Document -
Attachment Id: 16072
File Name: GA45329 Subject Questionnaire Eligibility Checklist Version 4 Dated 12June2025 .docx
URL:
Objective
To evaluate the efficacy of RO7790121 compared with placebo in inducing remission.
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A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Crohns Disease. +
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Crohns Disease.
Protocol No: GA45331
Age Group: Adult
Disease Sites: Crohn's Disease
NCT Id: NCT06819878
Phase: III
Principal Investigators: Udayakumar Navaneethan, MD
Eligibility Document -
Attachment Id: 16393
File Name: GA45331 Subject Screening Eligibility Checklist Questionnaire Version 2 Date 05May2025.docx
URL:
Objective
To evaluate the efficacy of RO7790121 compared with placebo in maintaining response
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Registry of Patients Undergoing EUS-Guided Gallbladder Drainage +
Registry of Patients Undergoing EUS-Guided Gallbladder Drainage
Protocol No: GB-DRAINAGE
Age Group: Adult
Disease Sites: Gallblader Disease
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Ji Bang, MD
Objective
The primary outcome measure is the treatment success of patients undergoing EUS-guided gallbladder drainage
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Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial +
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Protocol No: HBOT-UC
Age Group: Adult
Disease Sites: Ulcerative Colitis
NCT Id: NCT05987852
Phase: N/A
Principal Investigators: Udayakumar Navaneethan, MD
Objective
This study is measuring how many patients with rectal bleeding and frequent stools improve by day 5 without needing stronger medications or surgery.
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An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis +
An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
Protocol No: I7P-MC-DSAG
Age Group: Adult
Disease Sites: Ulcerative Colitis
NCT Id: NCT06598943
Phase: II
Principal Investigators: Udayakumar Navaneethan, MD
Eligibility Document -
Attachment Id: 13496
File Name: I7P-MC-DSAG_Amendment a Dated 04-JUN-2024 Subject Eligibility _Screening Checklist.docx
URL:
Objective
To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC
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Evaluating Multiple Combination Therapy of Biologics and Small Molecules for Ulcerative Colitis and Crohn's Disease. +
Evaluating Multiple Combination Therapy of Biologics and Small Molecules for Ulcerative Colitis and Crohn's Disease.
Protocol No: IBD
Age Group: Adult
Disease Sites: Crohn's Disease, Ulcerative Colitis
NCT Id: NCT99999999
Phase: N/A
Principal Investigators: Udayakumar Navaneethan, MD
Objective
The primary outcome measure is to assess the safety and effectiveness of various combinations of DBTs and SBTs in those with UC and CD through clinical and endoscopic remission.
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Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections. +
Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections.
Protocol No: PANCREATIC-FLUID-COLLECT-REG
Age Group: Adult
Disease Sites: Pancreatic Disease
NCT Id: NCT06179459
Phase: N/A
Principal Investigators: Ji Bang, MD
Objective
The primary outcome measure is to evaluate the treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
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Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture- Bowel +
Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture- Bowel
Protocol No: PATENT-B
Age Group: Adult
Disease Sites: Bowel Stricture
NCT Id: NCT05561127
Phase: N/A
Principal Investigators: Udayakumar Navaneethan, MD
Objective
This study is checking how well the treatment opens up the esophagus without needing another procedure within 6 months, and how often serious side effects like bleeding or injury happen within 30 days.
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Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture- Esophagus +
Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture- Esophagus
Protocol No: PATENT-E
Age Group: Adult
Disease Sites: Esophageal Stricture
NCT Id: NCT05561114
Phase: N/A
Principal Investigators: Robert Hawes, MD
Eligibility Document -
Attachment Id: 15272
File Name: Subject Eligibility _Screening Checklist_PATENT-E Version E.docx
URL:
Objective
This study is looking at how well the treatment helps patients swallow more easily without needing another procedure within six months, and how often serious side effects happen within 30 days.
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A Phase 2A, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants with Predicted Severe Acute Pancreatitis +
A Phase 2A, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants with Predicted Severe Acute Pancreatitis
Protocol No: RABI-767-201
Age Group: Adult
Disease Sites: Pancreatitis
NCT Id: NCT06080789
Phase: II
Principal Investigators: Charles Wilcox, MD
Eligibility Document -
Attachment Id: 16812
File Name: RABI-767-201 Version 3.1 23Sep2024 - Subject Eligibility _Screening Checklist.pdf
URL:
Objective
To evaluate the safety of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis.
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Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts +
Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
Protocol No: RECTAL-INDO-PAN-CYSTS
Age Group: Adult
Disease Sites: Pancreatic Disease
NCT Id: NCT05572788
Phase: N/A
Principal Investigators: Ji Bang, MD
Eligibility Document -
Attachment Id: 16412
File Name: IndoPanCysts Version 22Dec2022 - Subject Eligibility _Screening Checklist.pdf
URL:
Objective
The primary outcome measure is to compare the rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts between the indomethacin group and placebo group.
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A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease +
A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease
Protocol No: VEDOLIZUMAB-3043
Age Group: Adult
Disease Sites: Crohn's Disease
NCT Id: NCT06227910
Phase: III
Principal Investigators: Udayakumar Navaneethan, MD
Eligibility Document -
Attachment Id: 13663
File Name: Vedolizumab-3043 version 4 01may2025 - Subject Eligibility _Screening Checklist.pdf
URL:
Objective
This study is checking how many people with Crohns disease feel better and show healing in their intestines after 12 weeks of treatment, based on symptom scores and results from a scope exam.
New treatments follow strict guidelines and must be approved by the U.S. Food and Drug Administration (FDA) before they are made available for standard use. Clinical trials are a key part of that process.
Contact Us
If you would like more information on a specific clinical trial, please reach out to BJ Broome, MBAHM, Senior Director, Research and Clinical Trial Operations at (321) 841–4356
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Information will update every 5 minutes. ER Wait Times are approximate and provided for informational purposes only. Estimated Wait Times as of: Friday, November 21, 2025 5:18 AM
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