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

Sponsor
Endogenex, Inc.
Study ID
NCT07768631
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • pulsENDO Therapy — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Nov 1, 2029
Completion
Nov 1, 2030

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: pulsEndo Arm
    Arm to receive pulsENDO therapy
  • No Intervention: Sham Contorl Arm
    Control arm receives sham procedure
  • Experimental: Run-in Arm
    Initial open-label run-in cohort (n=30) generates early safety data

Primary Outcome Measure

Change in HbA1c [ Time Frame: From baseline to 6 months post-procedure ]

Central Contacts

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