Obesity
Conditions
Keywords
Obesity Surgery
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.
Detailed description
STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) DESIGN: Prospective, open-label, and single center
Interventions
PROCEDURELaparoscopic 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).
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 12 months | The primary effectiveness endpoint is % of subjects who attain clinically successful weight loss at one year post LGCP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity rates | 12 months | Morbidity rates |
| Mortality rates | 12 month | Mortality rates |
Countries
United States
Outcome results
None listed