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Diabetes Mellitus, Type 2NCT06724822

RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus

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 test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa… 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
12 participants
Where
1 siteChile
Study dates
14 Nov 2024to 30 Jun 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

  • Subjects previously enrolled and treated in the STEAM T2DM Clinical study.
  • Subjects with improvement in HbA1c of ≤0.5% or with HbA1c of ≥ 7.5% at the 6-month visit while participating in the STEAM T2DM study.
  • Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD except for glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.
  • Able to comply with study requirements and understand and sign the Informed Consent Form
  • Compliance with STEAM T2DM clinical protocol

Who cannot join

  • Non-compliance with STEAM T2DM clinical protocol
  • 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).
  • Current use of injectable medications for diabetes (insulin, GLP-1RA).
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  • Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes.
  • History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year).
  • 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 GI 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 chronic or acute pancreatitis.
  • History of diabetic gastroparesis.
  • 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 (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 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 GI 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)
  • Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at >500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.
  • 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.
  • Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic).
  • Estimated glomerular filtration rate (eGFR) ≤ 60 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)
  • Women breastfeeding
  • 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 Investigation of the Safety, Tolerability, Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Repeat Ablation Treatment for the Management of Type-2 Diabetes Mellitus (STEAM T-2 DM Retreatment Study) in Patients Who Were Non-Responders to Initial Duodenal Mucosal Ablation Treatment

The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa with RF vapor ablation.

Read the detailed description

The aims of the study are:

  1. Evaluate the safety of the device and retreatment 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 retreatment 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 who have received initial RF vapor ablation of the duodenal mucosa and had improvement in HbA1C of <0.5% at their six month evaluation.

Twelve subjects, previously enrolled in the STEAM T2DM Pilot study did not show adequate (>0.5%) response to initial RF vapor ablation treatment of the duodenal mucosa.

Minimum study duration per subject is 6 months.

The study comprises of 5 phases:

Screening, Pre-procedure tests, RF Vapor ablation procedure, Post vapor ablation follow up, identification and long term follow up of responders.

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 NCT06724822
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

    Change in HbA1c from baseline to 168 days post retreatment procedure

    Measured: 168 days

  3. Tolerability Endpoint

    Descriptive statistics on Visual Analogue Scale(VAS) pain scores

    Descriptive statistics on Visual Analogue Scale(VAS) pain scores

    Descriptive statistics on Visual Analogue Scale (VAS) pain scores

    Measured: 14 days

Secondary outcomes (9)

  1. Change in HbA1c at 84 days post retreatment procedure

    Change in HbA1c at 84 days post retreatment procedure

    Measured: 84 days

  2. Change in HbA1c over time

    Change in HbA1c by visit over time

    Measured: 168 days

  3. Change in FPG from baseline

    Change in Fasting Plasma Glucose from baseline to 84 and 168 days post retreatment procedure

    Measured: 168 days

  4. Change in FPG over time

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

    Measured: 168 days

  5. Proportion of ablation-treated subjects with an improvement in HbA1c from baseline

    Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 168 days.

    Measured: 168 days

  6. Change in HOMA-IR

    Changes in HOMA-IR by visit over time (168 days post procedure).

    Measured: 168 days

  7. Change in UACR

    Change in UACR from baseline to 168 days post retreatment procedure

    Measured: 168 days

  8. Change in ALT

    Change in ALT from baseline to 168 days post retreatment procedure.

    Measured: 168 days

  9. Change in AST

    Change in AST from baseline to 168 days post retreatment 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 posted9 Dec 2024
  2. Study start14 Nov 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724822
Sponsor's protocol ID
CLD-1023-SA
Status last verified
Nov 2025
First submitted
30 Nov 2024
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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 5 inclusion and 37 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 6 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 3 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 NCT06724822.

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 6 Nov 2025.

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