Actively Recruiting
REvision of VSG with Ablation of the Mucosa Procedure
Led by Dr. Christopher McGowan · Updated on 2024-11-05
5
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REvision of VSG with Ablation of the Mucosa Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with a BMI of 30 kg/m2 or greater
- Regained at least 25% of the total weight lost after initial successful sleeve gastrectomy
- Sleeve gastrectomy performed at least three years before enrollment
- Age between 22 and 60 years
- Agree to avoid weight loss medications and supplements during the study
- Women of childbearing potential must use acceptable contraception
- Agree not to donate blood during the study
- Able to comply with study requirements and sign informed consent
- Stable weight with less than 5% fluctuation for at least 3 months before screening
- History of failure to lose weight using conventional diet and lifestyle therapies
- Reliable access to wifi and/or internet services
- Willing to comply with lifelong dietary restrictions required by the procedure
You will not qualify if you...
- Inadequate response to sleeve gastrectomy
- Requirement for exogenous insulin
- HbA1c greater than 8.5%
- Pregnant, breast-feeding, or planning pregnancy during the study
- Unable or unwilling to complete pain assessments, questionnaires, or study visits
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Previous insulin use for more than 1 month except gestational diabetes
- Change in diabetic treatment within the last 3 months
- Use of certain glucose-lowering drugs except specific types
- GLP-1 use within the past 6 months
- Known autoimmune diseases except adequately replaced thyroid disease
- Previous endoscopic bariatric procedures or gastric implants
- History of diabetic gastroparesis
- Active liver disease other than specific fatty liver diseases
- Recent acute gastrointestinal illness
- History of irritable bowel syndrome, radiation enteritis, or inflammatory bowel disease
- Structural or functional esophageal disorders that may increase risk during endoscopy
- Structural or functional stomach disorders including gastroparesis and ulcers
- Chronic symptoms suggestive of stomach disorders
- Symptoms of intermittent small bowel obstruction
- Active H. pylori infection not adequately treated
- History of coagulopathy or upper gastrointestinal bleeding conditions
- Current anticoagulation therapy
- Use of anti-inflammatory drugs that cannot be stopped for 4 weeks post-procedure
- Recent systemic glucocorticoid use
- Use of drugs affecting gastrointestinal motility
- Current use of weight loss medications at screening
- Untreated or unstable hypothyroidism
- Persistent anemia with hemoglobin less than 10 g/dL
- Significant cardiovascular disease within last 6 months
- Moderate or severe chronic kidney disease
- Known immunocompromised status or recent chemotherapy/radiotherapy
- Active systemic infection
- Active malignancy within last 5 years except certain skin cancers
- 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 recent smoking history
- Participation in other clinical trials
- Any condition making the participant a poor candidate for the trial
- Other medical conditions preventing endoscopic procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
True You Weight Loss
Cary, North Carolina, United States, 27513
Actively Recruiting
Research Team
S
Shannon Casey, MS
CONTACT
C
Chase Wooley, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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