AzTrials
AzTrials

Type-2 Diabetes MellitusRESTORE-1NCT07355270

A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study)

A study testing RF Vapor Ablation in people with Type-2 Diabetes Mellitus, run by Aqua Medical, Inc. at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device… Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Type-2 Diabetes Mellitus
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
20 participants
Where
4 sitesUnited States
Study dates
1 Apr 2026to 31 Mar 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 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and non-pregnant women 22-65 years of age
  • Diagnosed with T2DM for at least 1 year and less than or equal to 15 years
  • HbA1C of 7.5 - 10% (58-86 mmol/mol)
  • BMI ≥ 24 and ≤ 40 kg/m2
  • On one or more non-insulin glucose-lowering medications, with no therapeutic changes in medication regimen for at least 12 weeks prior to the screening visit, to ensure stable glycemic control.
  • Note 1: Exception for sulfonylureas (SU): For safety reasons, subjects taking sulfonylureas (limited to glipizide or glimepiride only) will be required to undergo a protocol-mandated reduction to ≤50% of the maximum labeled dose during the run-in phase. This adjustment is intended solely to minimize the risk of hypoglycemia during intensive monitoring and dietary standardization and will not be considered a therapeutic change for purposes of eligibility. Subjects unwilling to comply with this dose reduction will be excluded.
Show all 12Show fewer
  • Note 2: GLP-1s are considered non-insulin glucose lowering medications.
  • 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.
  • Weight stability (defined as a < 5% change in body weight) in the 12 weeks prior to the screening visit. Participants should agree to refrain from using over the counter or herbal supplements intended for weight loss. Participants already on a prescribed weight loss drug should agree to not further titrate their medications during the study.
  • Women of childbearing potential must be using at least one acceptable method of contraception throughout the study
  • Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
  • 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 serum C-peptide of 0.3-0.6 nmol/l.
  • Current or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes) in the last 2 years.
  • Hypoglycemia unawareness as defined by a score of 4 or higher on a Gold score questionnaire suggestive of impaired awareness of hypoglycemia (IAH).
  • History of severe hypoglycemia (2 or more severe hypoglycemic event, as defined by need for third-party assistance, in the last 6 months from the screening visit).
Show all 38Show fewer
  • Subjects with untreated or unstable microvascular complications of diabetes such as retinopathy, nephropathy, and neuropathy. Subjects who have been appropriately treated/monitored and stable for the prior 3 months before study participation can be included as determined as safe and reasonable by the study PI.
  • Known systemic autoimmune disease that is uncontrolled or requiring steroids or biologics, including a positive anti-glutamic acid decarboxylase (GAD) test. Systemic autoimmune diseases include 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. (Participants with adequately controlled primary hypothyroidism or with mild to moderate psoriasis managed with topical therapy-affecting less than 10% of body surface area and not involving special areas (e.g., face, palms)-may be included).
  • Previous GI surgery that could limit access to the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Patients who have undergone a laparoscopic sleeve gastrectomy (LSG) or an endoscopic sleeve gastrectomy (ESG) procedure more than one year prior to enrollment will not be excluded from participation in this study.)
  • History of chronic pancreatitis or a diagnosis of idiopathic acute pancreatitis within the past 12 months.
  • Documented history of diabetic gastroparesis confirmed by gastric emptying study.
  • Known active hepatitis or liver disease, excluding nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD).
  • Symptomatic gallstones, or acute gastrointestinal illness in the previous 7 days.
  • Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel syndrome, such as Crohn's disease and Celiac disease.
  • Alcoholic liver disease, as indicated by ANI>-0.66 and AUDIT-C questionnaire
  • Known history of a structural or functional esophageal disorder that could impede endoscope passage or elevate the risk of esophageal injury during an endoscopic procedure, including but not limited to moderate-severe (Los Angeles Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices greater than Grade 2, history of esophageal perforation, or any other clinically significant esophageal condition.
  • Presence of upper gastrointestinal conditions, including active ulcers, varices, strictures, congenital or acquired proximal intestinal telangiectasia, active H. pylori infection.
  • Current use of anticoagulation therapy (vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOACs) that cannot be safely discontinued peri procedurally
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before and 7 days after the procedure.
  • Unable to discontinue high-dose non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin, PRN over the counter NSAIDs 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.
  • Persistent anemia, defined as hemoglobin <10 g/dl on two consecutive measurements >6 weeks apart.
  • Known history of hemoglobinopathy.
  • Known history of blood donation or transfusion within 3 months prior or screening or anticipated blood donation during the study period.
  • Significant cardiovascular disease, including known history of valvular heart disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 12 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) ≤ 45 ml/min/1.73m2 (estimated by MDRD).
  • Known immunocompromised status, including but not limited to: individuals who have undergone organ transplantation, receipt of chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia, confirmed human immunodeficiency virus (HIV) infection, or any other condition impacting immune function that, in the opinion of the investigator, renders the participant unsuitable for trial participation.
  • History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value >1.5x of the upper limit of normal range at screening)
  • In the opinion of the Investigator, the participant is not an appropriate candidate for upper GI endoscopy or general anesthesia.
  • Active illicit substance abuse or Alcohol Use Disorder (AUD) (consuming more than 14 drinks per week for men or more than seven drinks per week for women)
  • Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
  • Women who are currently breastfeeding
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Any other physical or mental condition that, in the opinion of the investigator, would make the participant an unsuitable candidate for clinical trial participation.
  • Critically ill or has a life expectancy <3 years.
  • Use of a cardiac pacemaker, implantable cardioverter-defibrillator (AICD), duodenal metallic implants, or any other implanted electronic medical devices.
  • General contraindications to deep or conscious sedation, general anesthesia, or upper gastrointestinal (GI) endoscopy, including individuals deemed high-risk by an anesthesiologist (e.g., ASA Physical Status Classification of IV or higher).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alina Stoica, CCRP contact

5622578114

astoica@aquaendoscopy.com

Raj Nihalani, MD contact

rnihalani@aquaendoscopy.com

United States4 sites, 4 recruiting

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599

    Jazmine McQueen, 919-918-5900, jazmine_mcqueen@med.unc.edu

    Nicholas J Shaheen, MD, MPH

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Cadence Cooper, 949-764-6896, cadence.cooper@hoag.org

    Jennifer Phan, MD

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85054

    Neil Santos, 4805745993, santos.neil@mayo.edu

    Rahul Pannala, MD

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    VIctoria Staenglen, 480-323-1292, vstaenglen@honorhealth.com

    James Swain, MD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device Effects (UADE).

Read the detailed description

The main aims of the study are :

Evaluate the safety of the device and procedure based on the reported adverse events that occur.

Evaluate device tolerability based on pain scores reported by patients. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post procedure.

The subject population for this study are adults (22-65 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, Pre-procedure tests, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days).

Being tested
RF Vapor Ablation
Keywords
RESTORE-1, Type-2 Diabetes Mellitus, T2DM, Diabetes
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • RF Vapor AblationDevice

    Also called Aqua Medical RF Vapor System

    RF Vapor ablation of the proximal intestinal mucosa

Study groups in NCT07355270
Study groupRoleWhat they receive
Study arm- RF Vapor Ablation arm (PIMA arm)ExperimentalThis 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: 6 months

  2. Tolerability endpoint

    Descriptive statistics on Visual Analogue Scale(VAS) pain scores (A Visual Analog Scale (VAS) pain score is a patient's self-reported measure of pain intensity, marked on a straight line scale from 0-10, with "no pain" at the zero-end and "worst imaginable pain" at 10.)

    Measured: 14 days

  3. Efficacy endpoint

    Change in HbA1c from baseline to 6 months post procedure

    Measured: 6 months

Secondary outcomes (6)

  1. Change in HbA1c at 3 months post procedure

    Change in HbA1c (from baseline) at 3 months post procedure will be analyzed

    Measured: 3 months

  2. Change in FPG from baseline to 3 months and 6 months post procedure

    Change in Fasting Plasma Glucose from baseline to 3 months and 6 months post procedure

    Measured: 6 months

  3. Proportion of ablation-treated subjects with an HbA1c improvement > 0.5% from baseline at 6 months.

    Proportion of ablation-treated subjects with an HbA1c improvement > 0.5% from baseline at 6 months.

    Measured: 6 months

  4. Change in HOMA-IR from baseline to 6 months post procedure.

    Change in HOMA-IR from baseline to 6 months post procedure.

    Measured: 6 months

  5. Change in UACR from baseline to 6 months post procedure.

    Change in Urine Albumin-Creatinine Ratio from baseline to 6 months post procedure.

    Measured: 6 months

  6. Change in ALT and AST from baseline to 6 months post procedure.

    Change in ALT and AST from baseline to 6 months post procedure.

    Measured: 6 months

Timeline

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

  1. First posted21 Jan 2026
  2. Study start1 Apr 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 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
Model description
Open label, prospective
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355270
Sponsor's protocol ID
CLD-1021-US
Acronym
RESTORE-1
Status last verified
Sep 2026
First submitted
20 Jan 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing RF Vapor Ablation in people with Type-2 Diabetes Mellitus, run by Aqua Medical, Inc. at 4 sites in United States.

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 12 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Contact Alina Stoica, CCRP (5622578114, astoica@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: 6 months). 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 NCT07355270.

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 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in