Endogenex, Inc.
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.
This is a prospective, multicenter, open-label, treatment-only study designed to enroll individuals who participated in the ReCET Study, were randomized to the sham control arm, completed study follow-up, and are eligible, consented for participation in this study, and elect to receive treatment with the Endogenex System.
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 diabe…
The Endogenex System procedure utilizes a catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum.