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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: SIPS the stomach, intestinal, pylorus, sparing procedure

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Parker, Colorado, United States, 80134
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital Celebration Health
  • New York
    • Mount Kisco, New York, United States, 10549
    • New York, New York, United States, 10001
  • North Carolina
    • Cary, North Carolina, United States, 27511
    • Durham, North Carolina, United States, 27701
  • Utah
    • Salt Lake City, Utah, United States, 84101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint is excess weight loss (EWL) at 12 months.	12 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2014
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): January 18, 2017

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COVSIPS0447