Bariatric Endoscopy for Treatment of Obesity

NCT04854317 | Recruiting DMC

• 1 other identifier: 0001501/12/05/2020
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg/m2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment \& Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.

Conditions

Obesity

Keywords

Weight; Obese; Endoscopic Sleeve Gastroplasty; Endoluminal Vertical Gastroplasty; Primary Obesity Surgical Endolumenal 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Total Body Weight Loss (TBWL percent)

  To evaluate the percentage of Total Body Weight Loss after each endoscopic bariatric procedure

  at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure

Secondary Outcomes (11)

• Percentage of Excess Weight Loss (EWL percent)

  at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure

• Safety in terms of occurrance intra-procedural, post-procedural and late adverse events (AEs).

  intra-procedural, up to 14 days and any time after 14 days

• Technical success rate

  intra-procedural

• Pain procedure-related

  the day before the procedure, at 12, 24 hours after the procedure

• Vomit procedure-related

  at 12, 24 hours after the procedure

Study Arms (3)

Patients undergoing Endoscopic Sleeve Gastroplasty

ACTIVE COMPARATOR

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Procedure: Endoscopic gastroplasty

Patients undergoing Endoluminal Vertical Gastroplasty

ACTIVE COMPARATOR

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Procedure: Endoscopic gastroplasty

Patients undergoing Primary Obesity Surgical Endolumenal 2

ACTIVE COMPARATOR

Obese patients with I, II, and III grade of obesity (BMI 30-44.99 kg/m2) and previous failed attempts of diet.

Procedure: Endoscopic gastroplasty

Interventions

Endoscopic gastroplasty PROCEDURE

Endoscopic Gastroplasty

Also known as: Apollo Overstitch Sx, Endomina, POSE2

Patients undergoing Endoluminal Vertical Gastroplasty; Patients undergoing Endoscopic Sleeve Gastroplasty; Patients undergoing Primary Obesity Surgical Endolumenal 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old;
• acceptance of written informed consent to undergo an EG;
• capability to understand and comply with the study protocol;
• obesity: a BMI of 30-34.99 kg/m2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery.

You may not qualify if:

• patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason;
• patients suffering from any condition which precludes compliance with study instructions;
• patients who underwent previous attempts at surgical or endoscopic bariatric therapy;
• patient has any allergy or other known contraindication or intolerance to the medications used in the study;
• women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice methods of contraception;
• patient suffers from a life threatening condition.

Sponsors & Collaborators

• Mater Olbia Hospital: lead

Study Sites (1)

Mater Olbia Hospital

Olbia, 07026, Italy

RECRUITING

Related Publications (17)

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• ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.

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  PMID: 27433904 BACKGROUND

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  PMID: 29551698 BACKGROUND

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• Marano G, Cuzzolaro M, Vetrone G, Garfinkel PE, Temperilli F, Spera G, Dalle Grave R, Calugi S, Marchesini G; QUOVADIS Study Group. Validating the Body Uneasiness Test (BUT) in obese patients. Eat Weight Disord. 2007 Jun;12(2):70-82. doi: 10.1007/BF03327581.

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  PMID: 15954234 BACKGROUND

• Vadala di Prampero SF, Geraci M, Cosseddu V, Rocchi C, Bazzu P, Simonelli I, Fiorani M, Formichetti J, Manzoni G, Di Maio F, Massidda M, Masia S, Puci M, Sotgiu G, Milano V, Mancini MA, Rinaldi PM, Giustacchini P, Costamagna G, Bulajic M. EFFECTS OF DIFFERENT TECHNIQUES OF ENDOSCOPIC GASTROPLASTY ON WEIGHT LOSS AMONG PATIENTS WITH OBESITY: A RANDOMIZED, SINGLE-CENTER PRAGMATIC TRIAL. Gastrointest Endosc. 2025 Dec 26:S0016-5107(25)02522-2. doi: 10.1016/j.gie.2025.12.271. Online ahead of print.

  PMID: 41456751 DERIVED

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

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

Study Officials

• Salvatore F. Vadalà di Prampero, MD, PhD

  Gastroenterology and GI Endoscopy

  PRINCIPAL INVESTIGATOR

• Milutin Bulajic, MD, PhD

  Gastroenterology and GI Endoscopy

  STUDY CHAIR

Central Study Contacts

Salvatore F. Vadalà di Prampero, MD, PhD

CONTACT

00393492666795; vadaladiprampero@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 22, 2021
• Study Start: June 19, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)