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Procedure

Gastric Mucosal Ablation for Obesity (REVAMP Trial)

N/A

Recruiting

Led By Christopher McGowan, MD, MSCR

Research Sponsored by Dr. Christopher McGowan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must agree to refrain from using specific weight loss medications and supplements throughout the study

Male and female patients with a BMI of 30 kg/m2 or greater who have regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy

Must not have

History of diabetic ketoacidosis or hyperosmolar nonketotic coma

Known autoimmune diseases, except for autoimmune thyroid disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if using a new technique called endoscopic selective gastric mucosal ablation (GMA) with argon plasma coagulation is safe and well-tolerated in patients who

Who is the study for?

This trial is for individuals who have regained weight after initially losing it following a sleeve gastrectomy surgery. It's not specified, but typically participants should be adults in stable health with no conditions that could interfere with the study.

What is being tested?

The trial is testing Gastric Mucosal Ablation (GMA) using argon plasma coagulation on patients post-sleeve gastrectomy to see if it's safe and can help manage weight regain.

What are the potential side effects?

While specific side effects are not listed, procedures like GMA may cause abdominal pain, nausea, bleeding or infection at the treatment site. Side effects depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to use certain weight loss drugs or supplements during the study.

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I have a BMI over 30 and have regained 25% of the weight I lost after sleeve gastrectomy.

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I am between 22 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had diabetic ketoacidosis or a severe diabetic coma before.

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I have an autoimmune condition, but it's only in my thyroid.

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I have been diagnosed with moderate or severe chronic kidney disease.

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I am not taking medications that affect my digestion or cause weight loss.

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My thyroid condition is not well-managed.

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I need insulin from an outside source.

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My weight loss surgery didn't work as expected.

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I have a history of bleeding disorders or stomach bleeding.

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I have a serious heart condition.

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I cannot undergo surgery or be given general anesthesia.

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I cannot undergo endoscopic procedures due to my health conditions.

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I have ongoing anemia.

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I have a weakened immune system.

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I currently have an infection that affects my whole body.

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I have not had any active cancer in the last 5 years.

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I have been diagnosed with Multiple Endocrine Neoplasia type 1.

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I am currently smoking or have smoked recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Gastric Sensory Function Assessment

Glucose Homeostasis Assessment

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gastric Mucosal Ablation (GMA) following sleeve gastrectomyExperimental Treatment1 Intervention

Subjects 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.

0 / 20Eligibility criteria met