LGCP (Laparoscopic Greater Curvature Plication) (LGCP)

A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Procedure: Laparoscopic Greater Curvature Plication (LGCP)

Detailed Description

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

DESIGN: Prospective, open-label, and single center

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Laparoscopic Greater Curvature Plication; Only one treatment arm

Procedure: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity rates	Morbidity rates	12 months
Mortality rates	Mortality rates	12 month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Fielding George, M.D., NYU SOM; Principal Investigator: Christine Fielding, M.D., NYU SOM; Principal Investigator: Marina Kurian, M.D., NYU SOM

Publications and helpful links

General Publications

• Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg. 2010 Jul;20(7):913-8. doi: 10.1007/s11695-010-0132-0.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 1, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Obesity Surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: R11-00797