LGCP (Laparoscopic Greater Curvature Plication)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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

DESIGN: Prospective, open-label, and single center

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Greater Curvature Plication

Only one treatment arm

Group Type EXPERIMENTAL

Laparoscopic Greater Curvature Plication (LGCP)

Intervention Type PROCEDURE

This procedure creates a small sized stomach by folding the stomach twice into itself vertically. The functional capacity of the stomach is decreased by 80% of its normal(At least two rows of five continuous stitches are placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum).

Interventions

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Laparoscopic Greater Curvature Plication (LGCP)

This procedure creates a small sized stomach by folding the stomach twice into itself vertically. The functional capacity of the stomach is decreased by 80% of its normal(At least two rows of five continuous stitches are placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No