Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

Part of paid clinical trials in Los Angeles, California.

Sponsor
Endogenex, Inc.
Study ID
NCT05014204
Status
Completed

Conditions

  • Diabetes
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Diabetes Type 2
  • Endocrine System Diseases
  • Glucose Metabolism Disorders
  • Metabolic Disease

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications.

Key Dates

Start date
Oct 29, 2021
Status verified
Oct 2025
Primary completion
May 29, 2024
Completion
May 29, 2025

Study Design

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

Arms

  • Experimental: Interventional
    All eligible patients will receive the endoscopic Endogenex procedure.

Primary Outcome Measure

Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE) [ Time Frame: 12 weeks post-procedure ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
Cuyuna Regional Medical CenterCrosbyMinnesota56441-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Los Angeles, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Southern California· Los Angeles, CACuyuna Regional Medical Center· Crosby, MNMayo Clinic· Rochester, MN

Related Studies