ObesityRESULTSNCT00566943
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
A study testing PSD Veritas Collagen Matrix and Roux-en-Y gastric by-pass surgery with no buttress in people with Obesity, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- PSD Veritas Collagen Matrix and Roux-en-Y gastric by-pass surgery with no buttress
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years or older
- Patient willing to comply with follow-up evaluations
- Patient understands nature of procedure and provides informed consent
- Female patient has stated that she is not pregnant and will not become pregnant during trial.
Who cannot join
- Patient currently enrolled in another device/drug trial that competes for same patient population
- Patient with short life expectancy (12 months) wherever the cause is not linked to obesity
- BMI is equal or less than 40 and equal to or less than 65
- Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery
- Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial.
- Patient has known sensitivity to bovine material
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
Read the detailed description
The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery. The study is designed as two separate patient groups. One will enroll patients into a group where linear staple lines are buttressed at the stomach. The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas.
- Conditions
- Obesity
- Being tested
- PSD Veritas Collagen Matrix, Roux-en-Y gastric by-pass surgery with no buttress
- Keywords
- Staple Line Reinforcement, Buttress
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSD Veritas Collagen MatrixDevice
Roux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss.
Roux-en-Y gastric by-pass surgery with no buttressProcedure or surgery
Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple lines including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). intestine or mesentery.
Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without buttress at the GJ anastomosis. Linear buttress at the stomach/pouch staple line is required. Receives: Procedure: Roux-en-Y gastric by-pass surgery with no buttress |
| PSD Veritas | Experimental | Linear Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas used as a staple line buttress at the stomach/pouch.
In addition to buttress of the stomach/pouch, patients may have PSD Veritas linear buttress at any of the following staple lines: intestine, mesentery, or anastomosis junction (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine).
Circular Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas circular buttress used as a staple line buttress at the GJ anastomosis. Linear buttress at the stomach/pouch is required. Receives: Device: PSD Veritas Collagen Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.
Measured: Discharge/ 30 days Linear Discharge/30/90 days Circular
Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.
Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.
Measured: Discharge/30 Linear Discharge/30/90 days Circular
Secondary outcomes (2)
Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group
Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.
Measured: Discharge and 30 days
Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.
Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.
Measured: Discharge, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Roger De La Torre, MD, Principal investigator, Division of General Surgery University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566943
- Sponsor's protocol ID
- CP1007, Rev C
- Acronym
- RESULTS
- Status last verified
- Jul 2011
- First submitted
- 29 Nov 2007
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial
- ClinicalTrials.gov ID
- NCT00566943
- Acronym / sponsor ID
- RESULTS / CP1007, Rev C
- Conditions
- Obesity
- Keywords
- Staple Line Reinforcement, Buttress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
Detailed description
The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery. The study is designed as two separate patient groups. One will enroll patients into a group where linear staple lines are buttressed at the stomach. The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Roux-en-Y gastric by-pass surgery with no buttressPatients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple lines including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). intestine or mesentery. Patients who have laparoscopic Roux-en-Y gastric by-pass surgery without buttress at the GJ anastomosis. Linear buttress at the stomach/pouch staple line is required. |
| PSD Veritas | Experimental | Device: PSD Veritas Collagen MatrixLinear Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas used as a staple line buttress at the stomach/pouch. In addition to buttress of the stomach/pouch, patients may have PSD Veritas linear buttress at any of the following staple lines: intestine, mesentery, or anastomosis junction (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine). Circular Peri-Strips Dry Veritas Group: Patients who have laparoscopic Roux-en-Y gastric by-pass surgery with PSD Veritas circular buttress used as a staple line buttress at the GJ anastomosis. Linear buttress at the stomach/pouch is required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 years or older
- Patient willing to comply with follow-up evaluations
- Patient understands nature of procedure and provides informed consent
- Female patient has stated that she is not pregnant and will not become pregnant during trial.
Key exclusion criteria (6 listed)
- Patient currently enrolled in another device/drug trial that competes for same patient population
- Patient with short life expectancy (12 months) wherever the cause is not linked to obesity
- BMI is equal or less than 40 and equal to or less than 65
- Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery
- Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial.
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 |
|---|---|---|
| PSD Veritas Collagen MatrixRoux-en-Y gastric by-pass surgery. Surgeon creates a small pouch from the stomach and then by-passes a large portion of the small intestine. The body cannot absorb as many calories or nutrients thus resulting in weight loss. | Device | PSD Veritas |
| Roux-en-Y gastric by-pass surgery with no buttressPatients who have laparoscopic Roux-en-Y gastric by-pass surgery without staple line buttress material. No buttress material will be used on staple line including stomach/pouch, anastomostic junctions, (gastrojejunostomy (GJ) gastric to intestine, or jejunojejunostomy (JJ) intestine to intestine intestine to mesentery. | Procedure or surgery | Control |
Primary outcome
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
Time frame: Discharge/ 30 days Linear Discharge/30/90 days Circular
Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.
Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.
Time frame: Discharge/30 Linear Discharge/30/90 days Circular
Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.
2 secondary outcomes
Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group
Time frame: Discharge and 30 days
Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.
Time frame: Discharge, 30 and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roger De La Torre, MD principal investigator
Division of General Surgery University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSD Veritas Collagen Matrix and Roux-en-Y gastric by-pass surgery with no buttress in people with Obesity, run by Baxter Healthcare Corporation at 1 site 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 6 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 19 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 1 site 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?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. (time frame: Discharge/ 30 days Linear Discharge/30/90 days Circular). The study lists 2 primary outcomes in all. 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 19 May 2017.