Evaluation of the Safety and Efficacy of a 6-month Intragastric Balloon
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon
时间窗: 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
次要结局
- 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)