A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Weight Loss
Study Overview
Brief Summary
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.
Detailed Description
STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)
DESIGN: Prospective, open-label, and single center
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Weight Loss
Time Frame: 12 months
The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.
Secondary Outcomes
- Morbidity rates(12 months)
- Mortality rates(12 month)
Investigators
Heekoung A Youn
Research coordinator
NYU Langone Health