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LGCP (Laparoscopic Greater Curvature Plication) (LGCP)

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ClinicalTrials.gov Identifier: NCT01393886
Recruitment Status : Withdrawn
First Posted : July 13, 2011
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Laparoscopic Greater Curvature Plication (LGCP) Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients
Study Start Date : June 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Morbidity rates [ Time Frame: 12 months ]
    Morbidity rates

  2. Mortality rates [ Time Frame: 12 month ]
    Mortality rates

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393886

United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Fielding George, M.D. NYU SOM
Principal Investigator: Christine Fielding, M.D. NYU SOM
Principal Investigator: Marina Kurian, M.D. NYU SOM
More Information

Additional Information:
Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01393886     History of Changes
Other Study ID Numbers: R11-00797
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Heekoung A Youn, New York University School of Medicine:
Obesity Surgery