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Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus

NCT05887635 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-24

No results posted yet for this study

Summary

The purpose of this clinical study is to test the hypothesis that RF vapor ablation of the duodenal mucosa will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation).

The main aims of the study are :

1. Evaluate the safety of the device and procedure based on the reported adverse events that occur.
2. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post procedure.
3. Evaluate device tolerability based on pain scores reported by patients. The subject population for this study are adults (18-65 years of age) with type-2 diabetes mellitus. Study participation is 6 months for each patient.

The study is comprised of 5 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days), Identification and long term follow up of responders

Conditions

  • Diabetes Mellitus Type 2

Interventions

DEVICE

RF Vapor Ablation

RF Vapor ablation of the duodenum

Sponsors & Collaborators

  • Aqua Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-02
Primary Completion
2026-01-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887635 on ClinicalTrials.gov