LGCP (Laparoscopic Greater Curvature Plication)

Study Overview
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Brief Summary
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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
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STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) DESIGN: Prospective, open-label, and single center

Official Title
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A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Greater Curvature Plication (LGCP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Greater Curvature Plication<br>Only one treatment arm | Procedure: Laparoscopic Greater Curvature Plication (LGCP)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rates | Morbidity rates | 12 months | 
| Mortality rates | Mortality rates | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity Surgery