NCT01393886撤回2 期
A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
The aim of this study is to find out the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive weight loss surgery that has the potential to reduce the complications associated with gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of an implant and without cutting stomach.
详细描述
STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)
DESIGN: Prospective, open-label, and single center
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age at the time of enrollment into the study;
- •Have a BMI of at least 30;
- •Subject is willing to give consent and comply with protocol evaluation and treatment schedules;
- •Subject agrees to refrain from any type of weight-loss drug (prescription or OCT) or elective procedure that affect body weight for the duration of the trial; and
- •HbA1C<11%
排除标准
- •History of previous malabsorptive bariatric procedures;
- •Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- •Any condition which precludes compliance with the study;
- •History or presence of pre-existing autoimmune connective tissue disease; and
- •Use of prescription or over the counter weight reduction medications or supplements within 30 days of the screening visit or the duration of study participation.
- •This study is a local study (NY, within 50 miles). This study is not a sponsored trial. Therefore, the procedure is not free.
结局指标
主要结局
Weight Loss
时间窗: 12 months
The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.
次要结局
- Morbidity rates(12 months)
- Mortality rates(12 month)
研究者
Heekoung A Youn
Research coordinator
NYU Langone Health
研究点 (1)
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