NCT04725890

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

Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Endogenex, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the DyaMX procedure and followed up for 48 weeks.

Conditions

• Type 2 Diabetes

Interventions

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

Timeline

• Start date: 2021-04-20
• Primary completion: 2024-03-01
• Completion: 2024-12-22
• First posted: 2021-01-27
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated device study