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Diabetes Mellitus Type 2STEAM T-2DMNCT05887635

Study of Duodenal Mucosal RF Vapor Ablation in Subjects 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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. 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
40 participants
Where
1 siteChile
Study dates
2 Sep 2023to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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
  • On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Subjects unwilling to reduce the dose of SU at the run-in period will be excluded.
  • Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD with the exception of 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

Who cannot join

  • 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).
  • Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes.
Show all 35Show fewer
  • 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.

Krithika Rupnarayan, MD contact

(925)223-6392

krupnarayan@aquaendoscopy.com

Bosmat Friedman contact

(925)223-6392

bosmat.f@promedoss.com

Chile1 site, 1 recruiting

  • Clinica Colonial

    Santiago

    Leonardo Rodriguez, MD

    Recruiting

Other trials in Chile

About this study

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

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 :

Read more
  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

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 NCT05887635
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 procedure

    Measured: 6 months

  3. Tolerability Endpoint:

    Descriptive statistics on Visual Analogue Scale(VAS) pain scores

    Measured: 14 days

Secondary outcomes (8)

  1. 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

    Measured: 168 days

  2. Change in HbA1c by visit over time

    Change in HbA1c by visit over time, comparing with baseline

    Measured: 168 days

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

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

    Measured: 168 days

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

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

    Measured: 168 days

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

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

    Measured: 168 days

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

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

    Measured: 168 days

  7. Change in UACR from baseline to 24 weeks post procedure

    Change in UACR from baseline to 24 weeks post procedure

    Measured: 24 weeks

  8. Change in ALT and AST from baseline to 24 weeks post procedure.

    Change in ALT and AST from baseline to 24 weeks post procedure.

    Measured: 24 weeks

Timeline

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

  1. First posted5 Jun 2023
  2. Study start2 Sep 2023
  3. Primary completionJan 2026 (estimated)
  4. Study completionJun 2026 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887635
Sponsor's protocol ID
CLD-1021-SA
Acronym
STEAM T-2DM
Status last verified
Oct 2024
First submitted
22 May 2023
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Norton BC, Papaefthymiou A, Telese A, Neiponice A, Hoebel PB, Vignolo P, Rodriguez Grunert LA, Haidry R. Radiofrequency vapor ablation for duodenal mucosal ablation in the treatment of type 2 diabetes: results from the first-in-human pilot study. IGIE. 2025 Mar 31;4(2):110-119. doi: 10.1016/j.igie.2025.03.008. eCollection 2025 Jun.

    PubMed 41646468

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 35 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. 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?

Results are not available in the source record.

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

Contact Krithika Rupnarayan, MD ((925)223-6392, krupnarayan@aquaendoscopy.com), or a site near the patient. 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 NCT05887635, which also lists 1 linked publication.

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 24 Oct 2024.

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