LGCP (Laparoscopic Greater Curvature Plication)

Phase 2

Withdrawn

• Conditions: Obesity
• Interventions: Procedure: Laparoscopic Greater Curvature Plication (LGCP)

• Registration Number: NCT01393886
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-05
• Study Start: 2013-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Greater Curvature Plication	Laparoscopic Greater Curvature Plication (LGCP)	Only one treatment arm

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 months	The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.

Secondary Outcome Measures

Name	Time	Method
Morbidity rates	12 months	Morbidity rates
Mortality rates	12 month	Mortality rates

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States