RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus

NCT06724822 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLD-1023-SA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa with RF vapor ablation.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Safety Endpoint

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

  1 month

• Efficacy Endpoint

  Change in HbA1c from baseline to 168 days post retreatment procedure

  168 days

• Tolerability Endpoint

  Descriptive statistics on Visual Analogue Scale(VAS) pain scores Descriptive statistics on Visual Analogue Scale(VAS) pain scores Descriptive statistics on Visual Analogue Scale (VAS) pain scores

  14 days

Secondary Outcomes (9)

• Change in HbA1c at 84 days post retreatment procedure

  84 days

• Change in HbA1c over time

  168 days

• Change in FPG from baseline

  168 days

• Change in FPG over time

  168 days

• Proportion of ablation-treated subjects with an improvement in HbA1c from baseline

  168 days

Other Outcomes (5)

• Long term follow up endpoints among responders: Change in HbA1c

  2 years

• Long term follow up endpoints among responders: Change in FPG

  2 years

• Long term follow up endpoints among responders: Proportion of responders

  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:

• Subjects previously enrolled and treated in the STEAM T2DM Clinical study.
• Subjects with improvement in HbA1c of ≤0.5% or with HbA1c of ≥ 7.5% at the 6-month visit while participating in the STEAM T2DM study.
• Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD except for glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.
• Able to comply with study requirements and understand and sign the Informed Consent Form
• Compliance with STEAM T2DM clinical protocol

You may not qualify if:

• Non-compliance with STEAM T2DM clinical protocol
• Diagnosis of Type-1 Diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Probable insulin production failure, defined as fasting C Peptide serum \<1 ng/mL (333pmol/l).
• Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes).
• Current use of injectable medications for diabetes (insulin, GLP-1RA).
• Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes.
• 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 chronic or acute pancreatitis.
• History of diabetic gastroparesis.
• 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.

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 Officials

• Leonardo Rodriguez, MD

  Clinica Colonial, Santiago, Chile

  PRINCIPAL INVESTIGATOR

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: November 30, 2024
• First Posted: December 9, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)