Trials / Not Yet Recruiting
Not Yet RecruitingNCT06585371
Evaluation of a 6-month Intragastric Balloon
Evaluation of the Safety and Efficacy of a 6-month Intragastric Balloon
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 46 (estimated)
- Sponsor
- MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Post-market observational, adaptive, single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon. Patients will be followed for 6 months after the device is installed.
Detailed description
Forty-six overweight patients over 18 years of age with a BMI of 27 kg/m2 or greater who are considered suitable for intragastric balloon placement will be included. The primary outcome will be the assessment of the percentage of total weight loss (%WL) at 6 months. Patients will be screened in an outpatient setting at the participating research center. All participants who meet the eligibility criteria will be invited to participate in the study, which includes a screening visit, standard intragastric balloon placement procedure, and follow-up visits.
Conditions
Timeline
- Start date
- 2024-09-15
- Primary completion
- 2025-03-15
- Completion
- 2025-10-31
- First posted
- 2024-09-05
- Last updated
- 2024-09-05
Source: ClinicalTrials.gov record NCT06585371. Inclusion in this directory is not an endorsement.