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

ConditionDiabetes Mellitus Type 2

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAqua Medical, Inc.

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 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 5 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days), Identification and long term follow up of responders

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

RF Vapor Ablation
Device
RF Vapor ablation of the duodenum

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Study arm- RF Vapor Ablation armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety endpoint

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

Time frame

1 month

Efficacy endpoint

Change in HbA1c from baseline to 168 days post procedure

Time frame

6 months

Tolerability Endpoint:

Descriptive statistics on Visual Analogue Scale(VAS) pain scores

Time frame

14 days

Secondary outcomes

Change in HbA1c at 84 and 168 days post procedure

Change in HbA1c (from baseline) at 84 and 168 days post procedure will be analyzed

Time frame

168 days

Change in HbA1c by visit over time

Change in HbA1c by visit over time, comparing with baseline

Time frame

168 days

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

Time frame

168 days

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

Time frame

168 days

Other outcomes

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

Change in HbA1c over time

Time frame

2 years

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

Change in FPG across each visit over time

Time frame

2 years

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

Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 2 years.

Time frame

2 years

Long term follow up endpoints among responders: Changes in HOMA-IR

Changes in HOMA-IR by visit over time

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aqua Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov

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