A Prospective Study to Evaluate the Safety and Efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) Operations for Patients With BMI Between 30-40 kg/m2 With Co-morbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
研究概览
简要总结
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
详细描述
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA
STUDY OBJECTIVES
- To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
- To determine long-term effects on patients' co-morbidities
STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 and equal to or less than 60 years of age.
- •BMI of at least 30 and maximum BMI of 40 with co-morbidities
- •Willingness to comply with dietary restrictions required by the protocol
- •History of obesity for at least 5 years
- •History of at least 6 months of documented failures with traditional non-surgical weight loss methods
- •Willingness to follow protocol requirements
- •If female with childbearing potential, using an appropriate form of contraception
排除标准
- •Age less than 18, age greater than 60
- •Pregnancy
- •History of major depressive disorder or psychosis
- •Previous bariatric surgery or previous gastric surgery
- •Presence of achalasia
- •Presence of portal hypertension, cirrhosis, and/or varices
- •Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
- •Patients with autoimmune connective tissue disorders
- •Patients with acute abdominal infections
- •Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
研究组 & 干预措施
LAGB for low BMI patients
the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
干预措施: LAP-BAND® Adjustable Gastric Band (LAGB®) (Device)
结局指标
主要结局
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
时间窗: 5 years
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
次要结局
- Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery(5 years)
- Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery(5 years)
- Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery(5 years)
研究者
Heekoung A Youn
Research coordinator
NYU Langone Health