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

NCT05887635 | Recruiting DMC FDA Device

• 1 other identifier: CLD-1021-SA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate the safety of the device and procedure based on the reported adverse events that occur.
2. 2.Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post procedure.
3. 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.

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 procedure

  6 months

• Tolerability Endpoint:

  Descriptive statistics on Visual Analogue Scale(VAS) pain scores

  14 days

Secondary Outcomes (8)

• Change in HbA1c at 84 and 168 days post procedure

  168 days

• Change in HbA1c by visit over time

  168 days

• Change in FPG from baseline to 84 and 168 days post procedure

  168 days

• Change in FPG change by visit over time (168 days post procedure)

  168 days

• Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 168 days

  168 days

Other Outcomes (6)

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

  2 years

• Long term follow up endpoints among responders: Change in Fasting Plasma Glucose (FPG) over time

  2 years

• Long term follow up endpoints among responders: Proportion of ablation-treated subjects with improvement from baseline

  2 years

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:

• Men and non-pregnant women 18-65 years of age
• Diagnosed with T2D for at least 3 years and less than or equal to 10 years
• HbA1C of 7.5 - 10% (59-86 mmol/mol)
• BMI ≥ 24 and ≤ 40 kg/m2
• Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD with the exception of 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

You may not qualify if:

• 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.
• 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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Krithika Rupnarayan, MD

CONTACT

(925)223-6392; krupnarayan@aquaendoscopy.com

Bosmat Friedman

CONTACT

(925)223-6392; bosmat.f@promedoss.com

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: May 22, 2023
• First Posted: June 5, 2023
• Study Start: September 2, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)