Clinical trial NCT02275208: A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
Official title: A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, multi-center, single-arm study. Patients who have elected to undergo bariatric surgery using the SIPS procedure (according to patient and investigator assessment and standard of care) will be evaluated for eligibility.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is excess weight loss (EWL) at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: SIPS-related adverse events at all timepoints
timeFrame: 12 months
measure: Resolution of comorbidities at 1, 6, and 12 months
timeFrame: 12 months
measure: Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Parker
country: United States
state: Colorado
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: