Evaluation of a 6-month Intragastric Balloon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Study Of The Procedure-less Intra-gastric Elipse Balloon: Is It Effective & Safe?

NCT03160469

Obese

COMPLETED NA

The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

NCT01061385

Obesity

COMPLETED NA

ReShape Intragastric Balloon for the Treatment of Obesity

NCT01024465

Obesity

COMPLETED NA

Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity

NCT03102697

Obesity Metabolic Syndrome

COMPLETED

Pilot Study to Evaluate A Novel Gastric Space Occupying Device

NCT01444274

Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity and Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;#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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes