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Diabetes Mellitus, Type 2STEAM-IENCT06655740

Safety, Tolerability, and Effectiveness of Duodenal Mucosal RF Vapor Ablation for Insulin Elimination in Type-2 Diabetes

A study testing RF Vapor Ablation in people with Diabetes Mellitus, Type 2, run by Aqua Medical, Inc. at 1 site in Chile.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
RF Vapor Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChile
Study dates
1 Oct 2024to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥18 years old but ≤ 65 years old. (Women of childbearing potential must be using one acceptable methods of contraception throughout the study.)
  • Diagnosed with type 2 diabetes mellitus for ≥1 year but ≤ 8 years duration.
  • Glycated haemoglobin ≤ 8.0% (64 mmol/mol).
  • Fasting serum C-peptide ≥ 0.6 ng/mL.
  • Body mass index ≥ 27.5 and ≤ 42.5 kg/m2.
  • On a daily insulin (basal or combined with short-acting) for at least three months, with a dose ≤ 0.6 U/kg, with a stable dose (≤ 20%) over the last month.
  • Able to comply with study requirements and understand and sign the informed consent form.

Who cannot join

  • Diagnosis of Type 1 diabetes mellitus
  • Any history of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Current use of insulin pump.
  • Current, or within the last 3 months, use of a GLP-1 analogue.
  • Current use of a long-acting sulphonylureas (e.g. glibenclamide, chlorpropamide, glimepiride, glyburide)
  • History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year).
Show all 38Show fewer
  • Known autoimmune disease, including but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder.
  • Previous gastrointestinal surgery that could limit treatment of the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Prior laparoscopic sleeve gastrectomy (LSG) will not be an exclusion).
  • History of pancreatitis (acute or chronic).
  • Known diabetic gastroparesis.
  • Persistent anaemia, defined as haemoglobin ≤ 9 g/dL
  • Known active hepatitis or active liver disease.
  • Acute gastrointestinal illness in the previous 7 days.
  • Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
  • Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including moderate-severe (Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices, esophageal perforation, or any other disorder of the esophagus.
  • Upper gastrointestinal conditions such as active ulcers, polyps, varices, strictures, congenital or acquired duodenal telangiectasia.
  • Current use of anticoagulation therapy (e.g. warfarin) or direct-acting oral anticoagulants (e.g. rivaroxaban, apixaban, edoxaban and dabigatran) that cannot be discontinued for 3-5 days before and 7 days after the procedure.
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 5 days before and 7 days after the procedure.
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
  • Use of drugs known to affect gastrointestinal motility (e.g. Metoclopramide)
  • Use of weight loss medications such as Sibutramine (e.g. Meridia), Orlistat (e.g. Xenical), Phentermine or over-the-counter weight loss medications (prescription medication)
  • Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  • Uncontrolled thyroid disease
  • Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic).
  • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 (estimated by MDRD).
  • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
  • Active illicit substance abuse or alcoholism (>2 drinks/day regularly)
  • Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
  • Active systemic infection
  • Women who are currently breastfeeding.
  • Pregnancy or wish to get pregnant in the next year.
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
  • Critically ill or has a life expectancy < 3 years.
  • Use of heart pacemaker or other electronic device implants
  • General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Clinica Colonial

    Santiago

Other trials in Chile

About this study

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

The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.

Read the detailed description

This is a prospective, open-label pilot, to determine safety and efficacy of step-up therapy with RFVA and Semaglutide

Being tested
RF Vapor Ablation
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RF Vapor AblationDevice

    RF Vapor ablation of the duodenum

Study groups in NCT06655740
Study groupRoleWhat they receive
Study arm- RF Vapor Ablation armExperimentalThis is a single arm study. All enrolled patients will be included in this arm
Receives: Device: RF Vapor Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Endpoint

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

    Measured: 1 month

  2. Efficacy Endpoint

    Percentage of patients free of insulin at 168 days post RF vapor ablation with an HbA1c ≤ 7.5% (58 mmol/mol)

    Measured: 168 days

Secondary outcomes (17)

  1. Technical success of duodenal mucosal ablation using RFVA

    The percentage of patients who underwent the procedure and received therapy to ≥ 6cm.

    Measured: 1 month

  2. Procedure time

    Procedure time of duodenal mucosal ablation, defined as the interval between catheter insertion and removal following completion of the procedure.

    Measured: 1 month

  3. Proportion of patients who remain free of insulin and Semaglutide

    • Proportion of patients who remain free of insulin and Semaglutide at 168 days (24 weeks) following RFVA with a HbA1c ≤ 7.5% (58 mmol/mol)

    Measured: 24 weeks

  4. Absolute change in HbA1c

    Absolute change in HbA1c at 84 days post-procedure.

    Measured: 84 days

  5. Absolute change in HbA1c by visit over time

    Absolute change in HbA1c by visit over time

    Measured: 168 days

  6. Change in fasting plasma glucose from baseline

    Change in fasting plasma glucose from baseline to 84 and 168 days post-procedure.

    Measured: 168 days

  7. Change in fasting plasma glucose by visit over time

    Change in fasting plasma glucose by visit over time (up to 168 days post-procedure).

    Measured: 168 days

  8. Change in HOMA-IR by visit over time

    Change in HOMA-IR by visit over time (up to 168 days post- procedure).

    Measured: 168 days

  9. Change in alanine transaminase

    Change in alanine transaminase from baseline to 168 days post-procedure.

    Measured: 168 days

  10. Change in aspartate transaminase

    Change in aspartate transaminase from baseline to 168 days post-procedure.

    Measured: 168 days

  11. Change in fibrosis index 4 (FIB-4) score

    Change in fibrosis index 4 (FIB-4) score between baseline to 84, baseline to 168 days and 84 to 168 days post-procedure.

    Measured: 168 days

  12. Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score

    Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score between baseline to 84, baseline to 168 days and 84 to 168 days post-procedure.

    Measured: 168 days

  13. Change in BMI

    Change in body mass index (BMI) between baseline to 84 and 168 days post-procedure.

    Measured: 168 days

  14. Reduction in insulin dose from baseline

    Reduction in mean and median dose of insulin from baseline to 168 days post procedure.

    Measured: 168 days

  15. Proportion of subjects with ≥50% reduction in their insulin dose at 168 days

    Proportion of subjects with ≥50% reduction in their insulin dose at 168 days post- procedure.

    Measured: 168 days

  16. Percentage of patients who remain off insulin

    Percentage of patients who remain off insulin at 168 days post-procedure.

    Measured: 168 days

  17. Proportion of patients who can tolerate semaglutide without need for discontinuation

    Proportion of patients who can tolerate semaglutide without need for discontinuation up to 168 days post-procedure.

    Measured: 168 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06655740
Sponsor's protocol ID
CLD-1022-SA
Acronym
STEAM-IE
Status last verified
Nov 2025
First submitted
22 Oct 2024
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing RF Vapor Ablation in people with Diabetes Mellitus, Type 2, run by Aqua Medical, Inc. at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoint (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06655740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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