Obesity and Overweight
Conditions
Keywords
intragastric, weight loss
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.
Interventions
None listed
Sponsors
MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon | From 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse event occurrence assessed by clinical evaluation | From the installation of the balloon to the end of treatment at 6 months | Adverse event monitoring through medical clinical evaluation |
| Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations | From the installation of the balloon to the end of treatment at 6 months | Patients will be weighed on an anthropometric balance during in-person consultations |
| BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations | From the installation of the balloon to the end of treatment at 6 months | To analyze the BMI changes, the BMI will be calculated in the follow-up medical consultations by dividing the weight (in kg) by the square of the height (in meters), according to the following formula: BMI = weight/(height x height) |
| Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations | From the installation of the balloon to the end of treatment at 6 months | To measure abdominal circumference, during in-person medical consultations, the patient will stand with arms extended at the side of the body, feet apart and parallel. The measuring tape will be positioned around the abdomen, midway between the lower costal margin and the iliac crest. |
Contacts
Primary ContactAnanda B Quevedo
Outcome results
None listed