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This study has been withdrawn prior to enrollment.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

June 9, 2011
February 1, 2013
June 2013
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01393886 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
LGCP (Laparoscopic Greater Curvature Plication)
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 OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)

DESIGN: Prospective, open-label, and single center

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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).
Experimental: Laparoscopic Greater Curvature Plication
Only one treatment arm
Intervention: Procedure: Laparoscopic Greater Curvature Plication (LGCP)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
December 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01393886
R11-00797
Yes
Heekoung A Youn, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Fielding George, M.D. NYU SOM
Principal Investigator: Christine Fielding, M.D. NYU SOM
Principal Investigator: Marina Kurian, M.D. NYU SOM
New York University School of Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP