Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study

NCT07197788 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 1421
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 12

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Type2diabetes; Diabetes Mellitus, Type 2; Type 2 Diabetes; Diabetes

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Incidence of device- and/or procedure-related serious adverse events

  6 months post-procedure

Other Outcomes (1)

• Changes in glycemic control

  6 months post-procedure

Study Arms (1)

Endogenex System Treatment

EXPERIMENTAL

Treatment arm will receive the Endogenex System procedure.

Device: Endogenex System

Interventions

Endogenex System DEVICE

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.

Endogenex System Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 procedures or conditions.
• Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including eosinophilic esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
• History of gastroparesis.
• Acute gastrointestinal illness in the last 7 days.
• Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease.
• History of chronic or acute pancreatitis.
• Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
• Current use of vitamin K antagonists such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally.

Sponsors & Collaborators

• Endogenex, Inc.: lead

Study Sites (12)

University of Alabama

Birmingham, Alabama, 35205, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Care Access

Quincy, Massachusetts, 02169, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Care Access

Raleigh, North Carolina, 27607, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital

Dallas, Texas, 75235, United States

Location

Care Access

Houston, Texas, 77054, United States

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 29, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); AU (2)