Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Greater Curvature Plication | Experimental | Only one treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity rates | Morbidity rates | 12 months |
| Mortality rates | Mortality rates | 12 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
This study is a local study (NY, within 50 miles). This study is not a sponsored trial. Therefore, the procedure is not free.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fielding George, M.D. | NYU SOM | Principal Investigator |
| Christine Fielding, M.D. | NYU SOM | Principal Investigator |
| Marina Kurian, M.D. | NYU SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20407932 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |