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

Recruiting N/A Interventional Study
Diabetes Mellitus Type 2
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Aqua Medical, Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 …
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Men and non-pregnant women 18-65 years of age 2. Diagnosed with T2D for at least 3 years and less than or equal to 10 years 3. HbA1C of 7.5 - 10% (59-86 mmol/mol) 4. BMI ≥ 24 and ≤ 40 kg/m2 5. On a minimum of 1 stable oral anti-diabetic medications with no changes in medicati…
Contacts

Krithika Rupnarayan, MD

(925)223-6392

krupnarayan@aquaendoscopy.com

CONTACT

Bosmat Friedman

(925)223-6392

bosmat.f@promedoss.com

CONTACT