LGCP (Laparoscopic Greater Curvature Plication)

Obesity Clinical Trial

— LGCP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01393886
• Other study ID #: R11-00797
• Status: Withdrawn
• Phase: Phase 2
• First received: June 9, 2011
• Last updated: February 1, 2013
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

DESIGN: Prospective, open-label, and single center

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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).

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.	12 months	Yes
Secondary	Morbidity rates	Morbidity rates	12 months	Yes
Secondary	Mortality rates	Mortality rates	12 month	Yes

External Links

•   Link