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

NCT06438510 | Recruiting

• 1 other identifier: 5646
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Safety, Tolerability and Efficacy of HybridAPC for gastric mucosa ablation of the fundus in patients undergoing endoscopic sleeve gastroplasty

  18 months

• HybridAPC

  To assess the additional effect of gastric mucosa ablation in the fundus by HybridAPC upon ESG on total body weight (Kilograms) over time

  18 months

Secondary Outcomes (3)

• Gastric Hormones

  18 months

• Life changes

  18 months

• Comorbidity

  18 months

Study Arms (1)

Single arm

EXPERIMENTAL

All patients undergo Endoscopic Sleeve Gastroplasty (ESG) and HybridAPC. ESG will be performed using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a gastroscope. Full- thickness sutures will be placed from the angulus to the gastric fundus using a U-shaped pattern with 2.0 nonabsorbable suture thread. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. HybridAPC is an highly controlled mucosal lift applied by the waterjet function and the subsequent thermal ablation applied by APC. First the fluid cushion is injected into submucosa until a size in the range of 2 - 3 cm is achieved (pressure setting of E20 up to E 30). Second the mucosa is being ablated on the surface of this fluid cushion (30 - 50 Watts, argon gas flow 0.8 L/min)

Procedure: Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)

Interventions

Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) PROCEDURE

All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied.

Single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ivo boskoski

  Fondazione Policlinico Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivo Boskoski

CONTACT

+390630156580; ivo.boskoski@policlinicogemelli.it

Ivo Boskoski

CONTACT

+390630156580; vo.boskoski@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 3, 2024
• Study Start: October 8, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

IT (1)