Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes

Sponsor
Endogenex, Inc.
Study ID
NCT04725890
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • The DyaMX Device — DEVICE
    The DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field. The DyaMX procedure is a non-surgical, endoscopic procedure.

Study Details

This is an open-label study to assess the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications.

Key Dates

Start date
Apr 20, 2021
Status verified
Mar 2025
Primary completion
Mar 1, 2024
Completion
Dec 22, 2024

Study Design

Enrollment
65 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    All eligible participants will receive the DyaMX procedure.

Primary Outcome Measure

Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE) [ Time Frame: At 12 weeks post procedure ]

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