Status:
NOT_YET_RECRUITING
Evaluation of a 6-month Intragastric Balloon
Lead Sponsor:
MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA
Conditions:
Obesity and Overweight
Eligibility:
All Genders
18+ years
Brief 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 afte...
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 as...
Eligibility Criteria
Inclusion
- Signed informed consent form;
- Age 18 or older;
- Both sexes;
- Being overweight, with a Body Mass Index (BMI) of 27 kg/m2 or higher;
- Being able to follow the protocol monitoring requirements;
- Adhering to the diet recommended by the nutrition professional;
- Presenting reasonable expectations of weight loss, at least 10% of baseline weight.
Exclusion
- Pregnant women or women during the breastfeeding period;
- People unable or unwilling to comply with restrictions regarding diet or medical monitoring and their respective guidelines during the program for use of the Intragastric Balloon;
- People with severe kidney and/or liver diseases;
- Patients who have undergone previous gastric surgery;
- Patients with inflammatory diseases of the gastrointestinal tract, gastric ulcer, duodenal ulcer or specific inflammations, such as Crohn\'s disease, or with a propensity for gastrointestinal bleeding in the upper tract, such as esophageal or gastric varices, or acquired intestinal telangiectasia;
- People with severe cardiopulmonary or organic disorders;
- People with congenital or acquired anomalies of the gastrointestinal tract, such as atresia and stenosis; with large hiatal hernia;
- Drug addicts in general;
- Patients not committed to adhering to treatment and medical recommendations, including nutritional guidance.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06585371
Start Date
September 15 2024
End Date
October 31 2025
Last Update
September 5 2024
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