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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-11

Study Completion Date

2017-01-18

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.

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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SIPS the stomach, intestinal, pylorus, sparing procedure

Bariatric Procedure

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No