Obesity
Conditions
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.
Interventions
PROCEDURESIPS the stomach, intestinal, pylorus, sparing procedure
Bariatric Procedure
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is excess weight loss (EWL) at 12 months. | 12 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed