Clinical trial

Evaluation of a 6-month Intragastric Balloon

Opening soon · Not applicable · 0 countries · Registry ID NCT06585371

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionObesity and Overweight

Full registry 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\'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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloonFrom the installation of the balloon to the end of treatment at 6 months

To analyze the percentage of total weight loss 6 months after installation of the intragastric balloon, the following formula will be used: Percentage of total weight loss = kilos lost/initial weight x 100

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.