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LGCP (Laparoscopic Greater Curvature Plication)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01393886
First received: June 9, 2011
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Procedure: Laparoscopic Greater Curvature Plication (LGCP)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.


Secondary Outcome Measures:
  • Morbidity rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Morbidity rates

  • Mortality rates [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Mortality rates


Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

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

DESIGN: Prospective, open-label, and single center

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393886

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

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
Study First Received: June 9, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Obesity Surgery

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013