NCT01393886

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.5 years

First QC Date

June 9, 2011

Last Update Submit

February 1, 2013

Conditions

Obesity

Keywords

Obesity Surgery

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP.

    12 months

Secondary Outcomes (2)

  • Morbidity rates

    12 months

  • Mortality rates

    12 month

Study Arms (1)

Laparoscopic Greater Curvature Plication

EXPERIMENTAL

Only one treatment arm

Procedure: Laparoscopic Greater Curvature Plication (LGCP)

Interventions

Laparoscopic Greater Curvature Plication (LGCP)PROCEDURE

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).

Laparoscopic Greater Curvature Plication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related 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.

    PMID: 20407932RESULT

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fielding George, M.D.

    NYU SOM

    PRINCIPAL INVESTIGATOR

  • Christine Fielding, M.D.

    NYU SOM

    PRINCIPAL INVESTIGATOR

  • Marina Kurian, M.D.

    NYU SOM

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research coordinator

Study Record Dates

First Submitted

June 9, 2011

First Posted

July 13, 2011

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)