Status:
COMPLETED
A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
Lead Sponsor:
Medtronic - MITG
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02275208
Start Date
December 11 2014
End Date
January 18 2017
Last Update
May 5 2017
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Parker, Colorado, United States, 80134
2
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
3
Mount Kisco, New York, United States, 10549
4
New York, New York, United States, 10001