Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

Conditions

• Diabetes
• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Type 2 Diabetes Mellitus
• Type2diabetes

Eligibility Criteria

Sex

ALL

Age

22 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• ReCET Treatment — DEVICE
  Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET 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. Participants will be followed for 12 months post procedure.
• Sham Procedure — DEVICE
  The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.

Study Details

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Key Dates

Start date

May 1, 2024

Status verified

Aug 2025

Primary completion

Apr 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

264 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: ReCET Arm
  Treatment Arm will receive the ReCET procedure.
• Sham Comparator: Control Arm
  Control Arm will receive a sham procedure.

Primary Outcome Measure

HbA1c [ Time Frame: 6 months post-procedure ]

Central Contacts

• Marie Steinbrink, MS
  (763) 251-6827
  [email protected]

Locations (38)

Find similar trials in Birmingham, AL

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