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

Completed

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02275208

Run by

Medtronic - MITG

People needed

120

Starts

2014-12-11

Expected to finish

2017-01-18

Last updated by the study team

2017-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Parker, Colorado, United States
• Florida Hospital Celebration Health — Celebration, Florida, United States
• Study site — Mount Kisco, New York, United States
• Study site — New York, New York, United States
• Study site — Cary, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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