Actively Recruiting
The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-06-03
20
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
CONDITIONS
Official Title
The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 65 years with class I to class II obesity (BMI 30 to 39.9).
- No prior bariatric surgery or endoscopic bariatric therapy.
- Evaluated and recommended for endoscopic sleeve gastroplasty (ESG) by the local multidisciplinary team.
- Willingness to follow the required behavioral modification program.
- Agree to avoid weight loss medications or supplements during the study.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception throughout the study.
- Able to understand and sign the informed consent form and comply with study requirements.
You will not qualify if you...
- Previous upper gastrointestinal surgery (except uncomplicated gallbladder or appendix removal) or other endoscopic bariatric procedures.
- Prior use of intra-gastric balloon or gastric implants.
- Structural or functional disorders of the esophagus or pharynx that could block device passage.
- Severe or uncontrolled gastro-esophageal reflux disease.
- Structural or functional stomach disorders such as large gastric polyps, gastroparesis, gastric ulcers, cancer, chronic gastritis, varices, or large hiatal hernia.
- Active Helicobacter pylori infection unless treated and confirmed eradicated.
- Intestinal strictures, obstructions, or other gastrointestinal blockages.
- Inflammatory bowel disease.
- Autoimmune diseases including celiac disease or systemic lupus erythematosus.
- Active liver disease or cirrhosis.
- Untreated or unstable hypothyroidism.
- Polycystic ovary syndrome.
- Persistent anemia with hemoglobin less than 10 g/dL.
- Significant cardiovascular disease or events in the last 6 months.
- Moderate to severe chronic kidney disease.
- Immunocompromised status or recent chemotherapy/radiotherapy.
- High HbA1c (>8.5%) or insulin-dependent diabetes.
- Use of certain glucose-lowering drugs not allowed.
- Coagulopathy or intestinal telangiectasia.
- Recent systemic glucocorticoid use.
- Pregnant or breastfeeding women.
- History or current substance abuse.
- Use of medications causing weight loss or gain (e.g., antidepressants).
- Psychiatric or compliance issues that prevent study participation.
- Any health condition posing risk as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
I
Ivo Boskoski
CONTACT
I
Ivo Boskoski
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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