The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 30, 2024

Keywords

ClinConnect Summary

The Fulness Trial is studying a new approach to help people with obesity achieve better weight loss and improve their health. Specifically, this trial examines a procedure called hybrid argon plasma coagulation (HYBRIDAPC) that treats a part of the stomach called the gastric fundus. It's believed that this treatment could help restore the function of certain cells that produce a hormone called ghrelin, which is involved in hunger regulation. Participants will undergo an endoscopic sleeve gastroplasty (ESG), a minimally invasive weight loss procedure, along with the study treatment.

To join the trial, participants should be between 18 and 65 years old and have a body mass index (BMI) between 30 and 39.9, which classifies them as having Class I or II obesity. They should not have had any previous weight loss surgeries and must be willing to make significant lifestyle changes as part of the program. Participants will be asked to avoid weight loss medications during the trial. If you're interested in learning more or think you might qualify, this could be a great opportunity to explore new ways to manage obesity with the support of a dedicated medical team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9).
• • Age between 18 and 65 years (both inclusive).
• • Treatment naïve for bariatric surgery or endoscopic bariatric therapy.
• • Patients that have been evaluated by the local MDT and have indication to ESG.
• • Willingness to comply with the substantial behavioral modifications program as required by the procedure.
• • Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
• • Women of childbearing potential should have negative urine beta human chorionic gonadotropin (hCG) pregnancy test and must agree to use acceptable contraception methods throughout the study duration.
• • Able to comply with study requirements and understand and sign the Informed Consent Form.
• Exclusion Criteria:
• • Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), or other endoscopic bariatric procedures or conditions,
• • Prior intra-gastric balloon or another gastric implant.
• • History of a structural or functional disorder of the esophagus or pharynx that may impede passage of the device such as achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolled GERD defined as LA grade C esophagitis or greater.
• • History of a structural or functional disorder of the stomach including gastric polyps \> 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronic gastritis, gastric varices, hiatal hernia (\>4 cm) of axial displacement of the z-line above the diaphragm.
• • 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).
• • Patients with history of intestinal stricture/stenosis, small bowel or colonic obstruction or any other obstructive disorder of the GI tract such as adhesive peritonitis and/or abdominal adhesions.
• • Patients with any inflammatory disease (IBD).
• • Autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
• • Active hepatitis, active liver disease, hepatic insufficiency , or cirrhosis.
• • Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening.
• • Patients with PCOS (hormonal dis-balances).
• • Persistent Anemia, defined as Hemoglobin \<10 g/dL.
• • Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months.
• • 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.
• • HbA1c \> 8.5 %.
• • Patients requiring exogenous insulin.
• • 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.
• • Coagulopathy, congenital or acquired intestinal telangiectasia.
• • 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.
• • Pregnant or breast-feeding woman.
• • Patients with history or current abuse of drugs or alcohol.
• • Patients who are taking medications that cause weight loss such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
• • Patients who are taking medication that cause weight gain such as anti-depressants
• • Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
• • Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

Trial Officials