Endogenex Open Access Study
Continued Access to the Endogenex System for Participants in the RECET Pivotal Study
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Clinical Trial Information
Trial Contact: Morales, Leticia
Trial Phone: 321.841.9623
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IRB No: W25.236.09
Protocol Abbrev: Endogenex Access Study
Principal Investigator: Andre F. Teixeira, MD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: 1421
Treatment: ReCET procedure
ClinicalTrials.gov ID: PENDING
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Objective
To collect real-world data on the safety and performance of the Endogenex System in the cohort of participants who were originally randomized to the sham control arm of the ReCET Study.
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Key Eligibility
1. Randomized to the sham control arm in the ReCET Study and completed their 12-month study visit.
2. HbA1c of 7.0-10.5%, inclusive
3. BMI <40 kg/m2, inclusive.
4. Agree not to donate blood during participation in the study.
5. Able to comply with study requirements and understand and sign the Informed Consent Form.
6. Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.
7. Willing and able to comply with study visits and study tasks as required per protocol.
