NCT06673550 Intragastric Balloon for Treatment of Overweight and Obesity: Which is the Best Filling Volume?
| NCT ID | NCT06673550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mater Olbia Hospital |
| Condition | Obese Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2022-08-20 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2022-08-20 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * age \> 18 years, obesity grade I-III, or overweight with at least one obesity-related comorbidity Exclusion Criteria: * history of bariatric surgery or endoscopy, allergies to methylene blue, childbearing or not willing to participate or comply with follow-up
Contact & Investigator
Salvatore F Vadala di Prampero
PRINCIPAL INVESTIGATOR
Mater Olbia Hospital
Frequently Asked Questions
Who can join the NCT06673550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Obese Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06673550 currently recruiting?
Yes, NCT06673550 is actively recruiting participants. Contact the research team at vadaladiprampero@gmail.com for enrollment information.
Where is the NCT06673550 trial being conducted?
This trial is being conducted at Olbia, Italy.
Who is sponsoring the NCT06673550 clinical trial?
NCT06673550 is sponsored by Mater Olbia Hospital. The principal investigator is Salvatore F Vadala di Prampero at Mater Olbia Hospital. The trial plans to enroll 156 participants.