Evaluation of a 6-month Intragastric Balloon

NCT06585371 | Not Yet Recruiting

• 1 other identifier: MEDICONE_01_2024
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity and Overweight

Keywords

intragastric; weight loss

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of Adverse event occurrence assessed by 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

  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

  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

  From the installation of the balloon to the end of treatment at 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA: lead

Related Publications (8)

• 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.

  PMID: 12119993 BACKGROUND

• Caballero B. Humans against Obesity: Who Will Win? Adv Nutr. 2019 Jan 1;10(suppl_1):S4-S9. doi: 10.1093/advances/nmy055.

  PMID: 30721956 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.

  PMID: 36510655 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.

  PMID: 17658025 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.

  PMID: 16189503 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.

  PMID: 28031749 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.

  PMID: 24488758 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.

  PMID: 32617919 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Ananda B Quevedo

CONTACT

+55 51 98111-0217; ananda.quevedo@medicone.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 5, 2024
• Study Start: September 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: October 31, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09