At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
The Endogenex Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes
In Brief
A clinical study evaluating The Endogenex Device for Diabetes and 6 related conditions. Completed, enrolled 20 participants across 3 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Type 2, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartOct 2021
Primary CompletionMay 2024
Study CompletionMay 2025
TodayJul 2026
First PostedAug 20, 2021
Enrollment StartOct 29, 2021
Primary CompletionMay 29, 2024
Study CompletionMay 29, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.9 years ago
Interventions
The Endogenex Devicedevice
The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field. The Endogenex procedure is a non-surgical, endoscopic procedure.