MedTrace Logo

Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes

NCT07768631 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-08-18

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.

Conditions

  • Diabetes Type 2
  • Diabetes
  • Diabetes (DM)
  • Weight Change
  • Glycemic Control
  • Glycemic Control for Diabetes Mellitus

Interventions

DEVICE

pulsENDO Therapy

The pulsENDO System is a catheter-based, non-thermal endoscopic therapy designed to promote controlled regeneration of the duodenal mucosa using pulsed electric field (PEF) technology. The treatment is controlled by the design of electrodes and waveform algorithm that concentrates the field to target the doudenal and jejunal cells of the small intestines.

Sponsors & Collaborators

  • Endogenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel DeMarco, M.D. · Baylor Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-11-01
Completion
2030-11-01
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768631 on ClinicalTrials.gov