LGCP (Laparoscopic Greater Curvature Plication)

NYU Langone Health

Status and phase

Withdrawn

Phase 2

Conditions

Obesity

Treatments

Procedure: Laparoscopic Greater Curvature Plication (LGCP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01393886

R11-00797

Details and patient eligibility

About

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.

Full description

STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)

DESIGN: Prospective, open-label, and single center

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.