Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05887635

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

Led by Aqua Medical, Inc. · Updated on 2024-10-24

40

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and non-pregnant women aged 18 to 65 years
  • Diagnosed with type 2 diabetes for at least 3 years and no more than 10 years
  • HbA1c between 7.5% and 10% (59-86 mmol/mol)
  • Body mass index (BMI) between 24 and 40 kg/m2
  • Taking at least one stable oral anti-diabetic medication with no changes in the last 3 months
  • Willing to use additional glucose-lowering treatment if recommended for persistent high blood sugar
  • Able to follow study requirements and give informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 diabetes
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Fasting C peptide serum less than 1 ng/mL (333 pmol/l) indicating probable insulin production failure
  • Previous insulin use for more than 1 month (except gestational diabetes treatment)
  • Current use of injectable diabetes medications (insulin, GLP-1 receptor agonists)
  • Current use of glyburide or other sulfonylurea drugs except specified types
  • History of more than one severe hypoglycemic event needing third-party help in the last year
  • Known autoimmune diseases including celiac, Crohn's, lupus, scleroderma, or other connective tissue disorders
  • Previous gastrointestinal surgeries that limit duodenal treatment like Billroth 2 or Roux-en-Y bypass (except laparoscopic sleeve gastrectomy)
  • History of pancreatitis or diabetic gastroparesis
  • Active liver disease or hepatitis
  • Recent acute gastrointestinal illness in the past 7 days
  • Severe irritable bowel syndrome or inflammatory bowel diseases
  • Structural or functional esophagus disorders that increase risk during endoscopy
  • Upper gastrointestinal conditions such as ulcers, polyps, varices, strictures, or telangiectasia
  • Use of anticoagulants or P2Y12 inhibitors that cannot be stopped as required
  • Inability to stop NSAIDs during treatment and recovery period
  • Recent systemic glucocorticoid use over 10 consecutive days within 12 weeks before baseline
  • Use of drugs affecting gastrointestinal motility or weight loss medications
  • Current use of certain dietary supplements or herbal agents including high-dose vitamin C or biotin
  • Significant cardiovascular disease or events within 6 months prior to screening
  • High blood pressure readings over specified limits
  • Reduced kidney function (eGFR ≤ 60 ml/min/1.73m2)
  • Immunocompromised states or recent chemotherapy, organ transplant, or HIV infection
  • Active substance abuse or alcoholism
  • Active malignancy within last 5 years (except non-melanoma skin cancers)
  • Women who are breastfeeding
  • Participation in another clinical trial of an investigational drug or device
  • Other medical or mental conditions judged unsuitable by the investigator
  • Critically ill or life expectancy less than 3 years
  • Use of pacemaker or electronic implants
  • Contraindications to sedation, anesthesia, or upper GI endoscopy as determined by anesthesiologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinica Colonial

Santiago, Chile

Actively Recruiting

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Research Team

K

Krithika Rupnarayan, MD

CONTACT

B

Bosmat Friedman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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