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Obesity and Obesity-related Medical ConditionsREVAMPNCT06671119

REvision of VSG with Ablation of the Mucosa Procedure

A study testing Gastric Mucosal Ablation (GMA) in people with Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by Dr. Christopher McGowan at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. Read more about this study

Who is it for?
Ages 22 to 60 years
What is being tested?
Gastric Mucosal Ablation (GMA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Dec 2024to May 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 22 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female patients who have:
  • BMI of 30 kg/m2 or greater, AND
  • regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%
  • Must have undergone SG at least three years before the time of enrollment
  • Age range: 22 - 60 years
  • Must agree to refrain from using weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dual GLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counter weight loss medications or supplements throughout the study.
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  • Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
  • Must agree not to donate blood during participation in the study.
  • Should be able to comply with study requirements, understand, and sign the Informed Consent Form.
  • Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.
  • Should have a history of failure to lose weight using conventional diet and lifestyle therapies.
  • Must have reliable access to wifi and/or internet services.
  • Must express willingness to comply with the substantial lifelong dietary restrictions required by the procedure.

Who cannot join

  • Inadequate response to sleeve gastrectomy
  • Patients requiring exogenous insulin.
  • HbA1c > 8.5%
  • Pregnant or breast-feeding or intending to get pregnant during the study.
  • Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
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  • Previous use of any types of insulin for > 1 month (at any time, except for treatment of gestational diabetes).
  • Change in diabetic treatment within the last three months.
  • Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors.
  • GLP-1 use in the preceding 6 months.
  • Known autoimmune disease, other than autoimmune thyroid disease, which is adequately replaced, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
  • Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
  • History of diabetic gastroparesis.
  • Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis.
  • Acute gastrointestinal illness in the previous 7 days.
  • Known history of 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 the risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus.
  • Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal reflux symptoms.
  • Known history of a structural or functional disorder of the stomach, including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3 cm), cancer, or any other disorder of the stomach.
  • Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia, or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting, or early satiety.
  • Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea, or vomiting.
  • Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
  • History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
  • Current use of anticoagulation therapy.
  • Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure.
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Use of drugs known to affect GI motility (e.g., Metoclopramide).
  • Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine, GLP-1 agonists, GIP/GLP-1 dual agonists, or over-the-counter weight loss medications at screening.
  • Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on a stable dose for at least 6 weeks prior to Screening.
  • Persistent Anemia, defined as Hemoglobin <10 g/dL.
  • Significant cardiovascular disease including a known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within the last 6 months.
  • Known moderate or severe chronic kidney disease (CKD), with 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 subject a poor candidate for clinical trial participation in the opinion of the Investigator.
  • Active systemic infection.
  • Known active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
  • Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
  • Not a candidate for surgery or general anesthesia.
  • Active illicit substance abuse or alcoholism.
  • Current smoker or smoking history in the last six months.
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
  • Other medical conditions that do not allow for an endoscopic procedure.

Trial locations and contacts

1 site in 1 country.

Shannon Casey, MS contact

(919) 391-7843

Shannon@trueyouweightloss.com

Chase Wooley, BS contact

(984) 345-2988

Chase@trueyouweightloss.com

United States1 site, 1 recruiting

  • True You Weight Loss

    Cary, North Carolina, 27513

    Chase Wooley, BS, (984) 345-2988, Chase@trueyouweightloss.com

    Shannon Casey, MS, (919) 391-7843, Shannon@trueyouweightloss.com

    Recruiting

Other trials in United States

About this study

The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Read the detailed description

Obesity is a multifaceted chronic disease associated with substantial morbidity and mortality, leading to conditions like diabetes, cardiovascular diseases, and malignancies. Bariatric procedures, such as the sleeve gastrectomy, stand out as the current most effective long-term treatments for obesity. Despite its effectiveness, a significant number of patients experience weight regain during long-term follow-up. Endoscopic minimally invasive bariatric intervention has been proposed as a viable, safe, and effective option for the treatment of weight regain after SG. Gastric mucosal ablation (GMA), in particular, is hypothesized to be a safe and effective endoscopic revisional treatment for weight regain following sleeve gastrectomy based on previous positive pre-clinical and clinical studies. To investigate the feasibility, safety, and tolerability of GMA after sleeve gastrectomy, a single procedure is designed to ablate the gastric mucosa of the pseudo greater curvature created after the sleeve gastrectomy in a single endoscopic session. We hypothesize that endoscopic selective ablation of the gastric mucosa after sleeve gastrectomy is effective as a revisional treatment for weight regain and will result in significant metabolic improvements.

Being tested
Gastric Mucosal Ablation (GMA)
Keywords
obesity, obesity and overweight, endoscopic bariatric therapy, ablation, gastric mucosal ablation, GMA
Medical subject headings
Obesity, Overweight

What participants receive

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

  • Gastric Mucosal Ablation (GMA)Device

    Endoscopic Gastric Mucosal Ablation (GMA) after sleeve gastrectomy

Study groups in NCT06671119
Study groupRoleWhat they receive
Gastric Mucosal Ablation (GMA) following sleeve gastrectomyExperimentalSubjects will undergo endoscopic Gastric Mucosal Ablation (GMA) following sleeve gastrectomy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.
Receives: Device: Gastric Mucosal Ablation (GMA)

What is being measured

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

  1. Percent Change in Total Body Weight Loss (TBWL) from Baseline

    Measure percent change in total body weight over time following endoscopic GMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

    Measured: 6 Months

Secondary outcomes (8)

  1. Rate of Safety Complications according to Clavien-Dindo Classification

    Occurrence of complications according to the Clavien-Dindo classification

    Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

  2. Rate of Adverse Events (AE)

    Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.

    Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

  3. Post-operative Pain Assessment

    Visual Analog Scale pain score at baseline compared to postoperative follow-up visits. The VAS Pain Scores range from 0 (minimum) to 10 (maximum), where 0 represents no pain and 10 represents the maximum level of pain, with higher scores indicating greater intensity of postoperative pain.

    Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

  4. Percent Change in Total Body Weight Loss (TBWL) from Baseline

    Measure percent change in total body weight over time following endoscopic GMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term

    Measured: Month 12

  5. Quality of Life Assessment

    Baseline quality of life assessment scores compared to 6 Month quality of life assessment scores. Quality of life score assessed and measured by the 36-Item Short Form Survey and The Impact of Weight on Quality of Life-Lite questionnaires. Scoring for both questionnaires range from 0 (minimum) to 100 (maximum). Higher scores for both questionnaires indicate higher quality of life.

    Measured: 6 Months

  6. Glucose Homeostasis Assessment

    Baseline measured fasting glucose, HOMA-IR, and HbA1c levels compared to post-intervention fasting levels at 3 Months and 6 Months using laboratory testing.

    Measured: 3 Months, 6 Months

  7. Serum Levels of Lipids Assessment

    Baseline compared to post-intervention fasting serum lipids levels at 3 Months and 6 Months measured by laboratory testing.

    Measured: 3 Months, 6 Months

  8. Gastric Sensory Function Assessment

    Volume to comfortable fullness and Maximum Tolerated Volume measured using a visual analog scale at 3 Months and 6 Months. Volume to Comfortable Fullness and Maximum Tolerated Volume scores both range from 0 (minimum) to 100 (maximum) with a lower score indicating a smaller required volume to reach comfortable fullness and maximum fullness.

    Measured: 3 Months, 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 posted4 Nov 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 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
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671119
Sponsor's protocol ID
20242649
Acronym
REVAMP
Status last verified
Oct 2024
First submitted
31 Oct 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Bulajic M, Vadala di Prampero SF, Boskoski I, Costamagna G. Endoscopic therapy of weight regain after bariatric surgery. World J Gastrointest Surg. 2021 Dec 27;13(12):1584-1596. doi: 10.4240/wjgs.v13.i12.1584.

    PubMed 35070065

  • Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.

    PubMed 27048439

Questions about this trial

What is this clinical trial studying?

A study testing Gastric Mucosal Ablation (GMA) in people with Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by Dr. Christopher McGowan at 1 site 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 13 inclusion and 42 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 5 Nov 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 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?

Results are not available in the source record.

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

Contact Shannon Casey, MS ((919) 391-7843, Shannon@trueyouweightloss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Total Body Weight Loss (TBWL) from Baseline (time frame: 6 Months). 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 NCT06671119, which also lists 2 linked publications.

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 5 Nov 2024.

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