A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure

Study Overview
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Brief Summary
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This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure. Subjects who meet the eligibility criteria will be considered for study participation and will be followed through 12 months.

Detailed Description
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SIPS is a single-anastomosis duodeno-intestinal switch procedure. Preliminary data from Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. CovidienTM plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the SIPS procedure.

Official Title
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A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure

Conditions
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Obesity

Intervention / Treatment
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* Procedure: SIPS the stomach, intestinal, pylorus, sparing procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be 18-65 years of age The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent The subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary SIPS procedure The subject has a BMI of 35-40 kg/m2 with at least 1 obesity-related comorbidity or a BMI of 40-60 kg/m2 Exclusion Criteria: Any female subject who is pregnant, or is actively breast-feeding Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity) The procedure is an emergency procedure The procedure is a revision/reoperation for the same indication The subject is unable or unwilling to comply with the study requirements or follow-up schedule The subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory) The subject has an estimated life expectancy of less than 6 months The subject has participated in an investigational drug or device research study within 30 days of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SIPS the stomach, intestinal, pylorus, sparing procedure|Bariatric Procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is excess weight loss (EWL) at 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIPS-related adverse events at all timepoints |  | 12 months | 
| Resolution of comorbidities at 1, 6, and 12 months |  | 12 months | 
| Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months |  | 12 months |