Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT05887635

Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus — STEAM T-2DM  

Diabetes Mellitus Type 2 Clinical Trial

Official title:
A Pilot Human Investigation of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Type-2 Diabetes Mellitus (STEAM T-2DM Pilot)

Clinical Trial 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 4 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05887635
Study type Interventional
Source Aqua Medical, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date September 2, 2023
Completion date October 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT01267448 - Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia Phase 4
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Terminated NCT02373865 - Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Phase 4
Completed NCT01741181 - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 Phase 4
Completed NCT01305434 - Mulberry Leaf Extract and Blood Glucose Control in Diabetics Phase 1/Phase 2
Completed NCT01330121 - Bridging the Gap by Transitional Care N/A
Recruiting NCT00992797 - Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity Phase 2
Completed NCT01580904 - Impact of Pharmaceutical Care in Diabetics Patients N/A
Active, not recruiting NCT00728403 - Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes Phase 2
Completed NCT00763815 - GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone Phase 3
Active, not recruiting NCT00529815 - Continuous Glucose Monitoring in Patients With Type 2 Diabetes Phase 4
Completed NCT00517465 - A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus. Phase 1
Withdrawn NCT00417716 - Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema Phase 3
Completed NCT00119041 - Diabetes Telemedicine Consultation: A Systems Improvement Intervention N/A
Withdrawn NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Completed NCT03903965 - Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
Completed NCT02666924 - Cooking Classes for Chinese Canadian Patients Living With Diabetes N/A
Recruiting NCT02501850 - The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) Phase 4
Completed NCT02318797 - Optimizing Behavioral Health Homes for Adults With Serious Mental Illness N/A