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)
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).
n/a
| 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 | |
| Completed |
NCT00119041 -
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
|
N/A | |
| Withdrawn |
NCT00417716 -
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
|
Phase 3 | |
| 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 |
NCT02001480 -
Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
|
N/A |