Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study (NCT07197788) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study
50 participantsStarted 2025-10
Plain-language summary
This study is designed 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.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* Randomized to the sham control arm in the ReCET Study and completed their 12-month study visit.
* HbA1c of 7.0-10.5%, inclusive
* BMI \<40 kg/m2, inclusive.
* Agree not to donate blood during participation in the study.
* Able to comply with study requirements and understand and sign the Informed Consent Form.
* Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.
* Willing and able to comply with study visits and study tasks as required per protocol.
Exclusion Criteria:
* Diagnosed with type 1 diabetes.
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
* Current use of insulin, or previous use of any types of insulin for \>1 month at any time (except for treatment of gestational diabetes) in last 2 years.
* Hypoglycemic unawareness.
* History of ≥1 severe hypoglycemia episode in past 6 months
* Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment.
* Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.
* Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar proced…