Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with intragastric balloon | Patients over 18 years old, who are overweight, have a BMI of 27 kg/m2 or greater and are going through intragastric balloon placement. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon | 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 | From the installation of the balloon to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse event occurrence assessed by clinical evaluation | Adverse event monitoring through medical clinical evaluation | From the installation of the balloon to the end of treatment at 6 months |
| Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ananda B Quevedo | Contact | +55 51 98111-0217 | ananda.quevedo@medicone.com.br |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12119993 | Background | Kolotkin RL, Meter K, Williams GR. Quality of life and obesity. Obes Rev. 2001 Nov;2(4):219-29. doi: 10.1046/j.1467-789x.2001.00040.x. | |
| 30721956 | Background | Caballero B. Humans against Obesity: Who Will Win? Adv Nutr. 2019 Jan 1;10(suppl_1):S4-S9. doi: 10.1093/advances/nmy055. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be weighed on an anthropometric balance during in-person consultations |
| From the installation of the balloon to the end of treatment at 6 months |
| BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations | 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) | From the installation of the balloon to the end of treatment at 6 months |
| Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations | 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. | From the installation of the balloon to the end of treatment at 6 months |
| 36510655 | Background | Lee KG, Nam SJ, Choi HS, Lee HL, Yoon JH, Park CH, Kim KO, Kim DH, Kim JW, Sohn W, Jung SH; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Efficacy and safety of intragastric balloon for obesity in Korea. Clin Endosc. 2023 May;56(3):333-339. doi: 10.5946/ce.2022.143. Epub 2022 Dec 13. |
| 17658025 | Background | Martinez-Brocca MA, Belda O, Parejo J, Jimenez L, del Valle A, Pereira JL, Garcia-Pesquera F, Astorga R, Leal-Cerro A, Garcia-Luna PP. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007 May;17(5):649-57. doi: 10.1007/s11695-007-9109-z. |
| 16189503 | Background | Genco A, Cipriano M, Bacci V, Cuzzolaro M, Materia A, Raparelli L, Docimo C, Lorenzo M, Basso N. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006 Jan;30(1):129-33. doi: 10.1038/sj.ijo.0803094. |
| 28031749 | Background | 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. |
| 24488758 | Background | 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. |
| 32617919 | Background | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |