Intragastric Balloon for Treatment of Overweight and Obesity: Which is the Best Filling Volume?

NCT06673550 | Recruiting DMC

• 1 other identifier: 0001501/28/08/2024
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

TITLE: Randomized study conducted in a single center, with the aim of comparing the three main filling volumes of the intragastric balloon in overweight or obese patients (BMI \>27 and \<60 kg/m2). OBJECTIVE: To establish the efficacy and safety of the intragastric balloon inflated to different volumes in patients who are candidates for balloon placement for overweight or obesity. To date there is no well-defined filling volume and each Endoscopist inflates the balloon to a random volume between 500 and 700 ml according to the experience acquired, but without a clear rationale. DESIGN: All overweight or obese patients with an indication for intragastric balloon placement will be preliminarily examined by a multidisciplinary team composed of a gastroeterologist, surgeon, nutritionist, psychologist, radiologist and endocrinologist. Before each bariatric procedure, patients will undergo a psychometric and nutritional evaluation in order to identify any psychopathological conditions that contraindicate the operation. The enrolled patients will be randomly divided to be candidates for balloon placement:

• 1/3 of patients will undergo treatment with an intragastric balloon inflated with 500 ml of saline solution and methylene blue, a space-occupying technique, which will be left in place for 1 year;
• 1/3 of patients will undergo treatment with an intragastric balloon inflated with 600 ml of saline solution and methylene blue;
• 1/3 of patients will undergo treatment with an intragastric balloon inflated with 700 ml of saline solution and methylene blue. All balloons will remain in place for 6 months, as per the instructions provided in the product technical data sheet. All the techniques described have already been widely validated by the scientific literature and are commonly used in bariatric endoscopy. Sample size: assuming a significant level of 0.05, to detect as significant a medium effect size (f=0.25) with a power of 80% performing an ANOVA model we will need to enrol 156 patients (52 in each group). Taking into account a possible 5% of drop-out at the enrollment, the total number of patients will be around 165 (55 per group). INFORMED CONSENT: Will be obtained upon first registration of the patient in the computer archive, as required by the hospital computer system, for access to personal data, which will be then used anonymously.

Conditions

Obese Patients

Keywords

Intragastric balloon

Outcome Measures

Primary Outcomes (1)

• Weight loss defined by percentage of Total Weight Loss and Excess Weight Loss

  The primary end point was weight loss defined by percentage of TWL (initial weight minus current weight) / (initial weight) x 100) and percentage EWL (initial weight minus follow-up weight) / (initial weight minus ideal weight for BMI 25) x 100%).

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (3)

• Adverse events (epigastric pain, nausea and vomiting)

  From enrollment to the end of treatment at 6 months

• Early balloon removal

  From enrollment to the end of treatment at 6 months

• Improvement of disease specific Quality of Life

  From enrollment to the end of treatment at 6 months

Study Arms (3)

Fluid filled intragastric balloon at a volume of 500 ml

EXPERIMENTAL

This arm will undergo a fluid-filled intragastric balloon palcement at a volume of 500 ml

Procedure: Intragastric balloon

Fluid filled intragastric balloon at a volume of 600 ml

EXPERIMENTAL

This arm will undergo a fluid-filled intragastric balloon palcement at a volume of 600 ml

Procedure: Intragastric balloon

Fluid filled intragastric balloon at a volume of 700 ml

EXPERIMENTAL

This arm will undergo a fluid-filled intragastric balloon palcement at a volume of 700 ml

Procedure: Intragastric balloon

Interventions

Intragastric balloon PROCEDURE

Randomized trial comparing fluide-filled intragastric balloon at different filling volumes.

Fluid filled intragastric balloon at a volume of 500 ml; Fluid filled intragastric balloon at a volume of 600 ml; Fluid filled intragastric balloon at a volume of 700 ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years, obesity grade I-III, or overweight with at least one obesity-related comorbidity

You may not qualify if:

• history of bariatric surgery or endoscopy, allergies to methylene blue, childbearing or not willing to participate or comply with follow-up

Sponsors & Collaborators

• Mater Olbia Hospital: lead

Study Sites (1)

Mater Olbia Hospital

Olbia, Italy

RECRUITING

Related Publications (1)

• Kumar N, Bazerbachi F, Rustagi T, McCarty TR, Thompson CC, Galvao Neto MP, Zundel N, Wilson EB, Gostout CJ, Abu Dayyeh BK. The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis. Obes Surg. 2017 Sep;27(9):2272-2278. doi: 10.1007/s11695-017-2636-3.

  PMID: 28285471 BACKGROUND

Study Officials

• Salvatore F Vadala di Prampero

  Mater Olbia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore F Vadala di Prampero

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: MD, PhD

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: August 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)