Safety, Tolerability, and Effectiveness of Duodenal Mucosal RF Vapor Ablation for Insulin Elimination in Type-2 Diabetes

NCT06655740 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLD-1022-SA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint

  Number of subjects with reported device or procedure related SAEs or UADEs.

  1 month

• Efficacy Endpoint

  Percentage of patients free of insulin at 168 days post RF vapor ablation with an HbA1c ≤ 7.5% (58 mmol/mol)

  168 days

Secondary Outcomes (17)

• Technical success of duodenal mucosal ablation using RFVA

  1 month

• Procedure time

  1 month

• Proportion of patients who remain free of insulin and Semaglutide

  24 weeks

• Absolute change in HbA1c

  84 days

• Absolute change in HbA1c by visit over time

  168 days

Study Arms (1)

Study arm- RF Vapor Ablation arm

EXPERIMENTAL

This is a single arm study. All enrolled patients will be included in this arm

Device: RF Vapor Ablation

Interventions

RF Vapor Ablation DEVICE

RF Vapor ablation of the duodenum

Study arm- RF Vapor Ablation arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old but ≤ 65 years old. (Women of childbearing potential must be using one acceptable methods of contraception throughout the study.)
• Diagnosed with type 2 diabetes mellitus for ≥1 year but ≤ 8 years duration.
• Glycated haemoglobin ≤ 8.0% (64 mmol/mol).
• Fasting serum C-peptide ≥ 0.6 ng/mL.
• Body mass index ≥ 27.5 and ≤ 42.5 kg/m2.
• On a daily insulin (basal or combined with short-acting) for at least three months, with a dose ≤ 0.6 U/kg, with a stable dose (≤ 20%) over the last month.
• Able to comply with study requirements and understand and sign the informed consent form.

You may not qualify if:

• Diagnosis of Type 1 diabetes mellitus
• Any history of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Current use of insulin pump.
• Current, or within the last 3 months, use of a GLP-1 analogue.
• Current use of a long-acting sulphonylureas (e.g. glibenclamide, chlorpropamide, glimepiride, glyburide)
• History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year).
• Known autoimmune disease, including but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder.
• History of pancreatitis (acute or chronic).
• Known diabetic gastroparesis.
• Persistent anaemia, defined as haemoglobin ≤ 9 g/dL
• Known active hepatitis or active liver disease.
• Acute gastrointestinal illness in the previous 7 days.
• Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
• Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including moderate-severe (Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices, esophageal perforation, or any other disorder of the esophagus.
• Upper gastrointestinal conditions such as active ulcers, polyps, varices, strictures, congenital or acquired duodenal telangiectasia.

Sponsors & Collaborators

• Aqua Medical, Inc.: lead

Study Sites (1)

Clinica Colonial

Santiago, Chile

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

CL (1)