This trial is active, not recruiting.

Condition obesity
Treatment sips the stomach, intestinal, pylorus, sparing procedure
Sponsor Medtronic - MITG
Start date November 2014
End date January 2016
Trial size 120 participants
Trial identifier NCT02275208, COVSIPS0447


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

The primary endpoint is excess weight loss (EWL) at 12 months.
time frame: 12 months

Secondary Outcomes

SIPS-related adverse events at all timepoints
time frame: 12 months
Resolution of comorbidities at 1, 6, and 12 months
time frame: 12 months
Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Medtronic - MITG.