ObesityNCT02275208
A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
An observational study of Obesity, run by Medtronic - MITG at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- SIPS the stomach, intestinal, pylorus, sparing procedure
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Dec 2014to 18 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Cary, North Carolina, 27511
Florida Hospital Celebration Health
Celebration, Florida, 34747
Study site
Durham, North Carolina, 27701
Study site
Mount Kisco, New York, 10549
Study site
New York, New York, 10001
Study site
Parker, Colorado, 80134
Study site
Salt Lake City, Utah, 84101
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- SIPS the stomach, intestinal, pylorus, sparing procedure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIPS the stomach, intestinal, pylorus, sparing procedureProcedure or surgery
Bariatric Procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is excess weight loss (EWL) at 12 months.
Measured: 12 months
Secondary outcomes (3)
SIPS-related adverse events at all timepoints
Measured: 12 months
Resolution of comorbidities at 1, 6, and 12 months
Measured: 12 months
Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start11 Dec 2014
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275208
- Sponsor's protocol ID
- COVSIPS0447
- Status last verified
- May 2017
- First submitted
- 23 Oct 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
- ClinicalTrials.gov ID
- NCT02275208
- Acronym / sponsor ID
- COVSIPS0447
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIPS the stomach, intestinal, pylorus, sparing procedureBariatric Procedure | Procedure or surgery | – |
Primary outcome
The primary endpoint is excess weight loss (EWL) at 12 months.
Time frame: 12 months
3 secondary outcomes
SIPS-related adverse events at all timepoints
Time frame: 12 months
Resolution of comorbidities at 1, 6, and 12 months
Time frame: 12 months
Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Medtronic - MITG at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is excess weight loss (EWL) at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.