Clinical trial NCT06585371: Evaluation of a 6-month Intragastric Balloon
Official title: Evaluation of the Safety and Efficacy of a 6-month Intragastric Balloon
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity and Overweight
Keywords: intragastric
weight loss
Lead sponsor: MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age who are overweight, with a Body Mass Index (BMI) of 27 kg/m2 or greater and who are considered fit to undergo the procedure for placement of the intragastric balloon

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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\&amp;amp;#39;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.

Primary outcomes:
measure: Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon
timeFrame: From the installation of the balloon to the end of treatment at 6 months
Secondary outcomes:
measure: Number of Adverse event occurrence assessed by clinical evaluation
timeFrame: From the installation of the balloon to the end of treatment at 6 months
measure: Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations
timeFrame: From the installation of the balloon to the end of treatment at 6 months
measure: BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations
timeFrame: From the installation of the balloon to the end of treatment at 6 months
measure: Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations
timeFrame: From the installation of the balloon to the end of treatment at 6 months
Other outcomes:
Locations:
Study officials:
References:
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citation: Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca LM, Godoy-Matos AF, Lopes AJ, Farias ML. Impact of a 6-month treatment with intragastric balloon on body composition and psychopathological profile in obese individuals with metabolic syndrome. Diabetol Metab Syndr. 2016 Dec 19;8:81. doi: 10.1186/s13098-016-0197-6. eCollection 2016.
citation: Buzga M, Evzen M, Pavel K, Tomas K, Vladislava Z, Pavel Z, Svagera Z. Effects of the intragastric balloon MedSil on weight loss, fat tissue, lipid metabolism, and hormones involved in energy balance. Obes Surg. 2014 Jun;24(6):909-15. doi: 10.1007/s11695-014-1191-4.
citation: Moore RL, Eaton L, Ellner J. Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. Obes Surg. 2020 Nov;30(11):4267-4274. doi: 10.1007/s11695-020-04798-5.