This trial is active, not recruiting.

Condition morbid obesity
Treatment laparoscopic gastric plication
Sponsor Ponce, Jaime, M.D.
Start date November 2010
End date June 2016
Trial size 50 participants
Trial identifier NCT01207609, 10-9-001


The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.

The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity
laparoscopic gastric plication Laparoscopic Greater Curvature Plication
The procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. A calibration tube or endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Primary Outcomes

Percent of excess weight loss
time frame: 3 years

Secondary Outcomes

Status of comorbid conditions
time frame: 3 years
Changes in quality of life scores from base line
time frame: 3 years
Adverse events
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Age: 18 - 60 years - BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2 - Willingness to comply with dietary restrictions required by the protocol - History of obesity for at least 5 years - History of at least 6 months of documented failures with traditional non-surgical weight loss methods - Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire - If female with childbearing potential, using an appropriate form of contraception Exclusion Criteria: - Age less than 18, age greater than 60 - Pregnancy - History of major depressive disorder or psychosis - Previous bariatric surgery or previous gastric surgery - Presence of achalasia - Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study

Additional Information

Official title A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
Principal investigator Jaime Ponce, MD
Description The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ponce, Jaime, M.D..