Colorectal CancerNCT00559013
Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
A study testing Staple line reinforcement in people with Colorectal Cancer, run by Baxter Healthcare Corporation at 2 sites in United States.
Trial summary
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Staple line reinforcement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to 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 must comply with follow-up evaluations
- Patient or representative must provide informed consent prior to enrollment
- Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
- Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location
Who cannot join
- Crohns disease
- Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
- Patients who have not had mechanical bowel preparation
- Patients with known documented sensitivity/allergy to bovine material
- Severe radiation damage to tissue
- Carcinomatosis or stage IV cancer
Show all 17Show fewer
- BMI is 35 or greater
- Cancer at primary anastomosis site that cannot be excised
- Patients who require an ileo rectal anastomosis
- Surgery anticipated to include jejunostomy pouch
- Anticipated diverting stoma
- No anti adhesive barrier can be used around anastomotic site
- No multiple circular anastomosis
- Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis
- Patient life expectacny less than follow-up timeframe of study
- Pregnancy
- Patients currently enrolled in a study that competes for the same patient population
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Colon & Rectal Surgery Associates
Saint Paul, Minnesota, 55105
About this study
Official title: Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
Read the detailed description
Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.
- Conditions
- Colorectal Cancer
- Being tested
- Staple line reinforcement
- Keywords
- Staple line reinforcement, Staple line buttress, Anastomotic reinforcement
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staple line reinforcementDevice
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PSD Veritas Collagen Matrix Reinforcement Arm Receives: Device: Staple line reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
Measured: Discharge and 1 Month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startMar 2007
- 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 Colorectal CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Richard Karulf, MD, Principal investigator, Colon & Rectal Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559013
- Sponsor's protocol ID
- CP1011, Rev C
- Status last verified
- Apr 2017
- First submitted
- 14 Nov 2007
- Last updated
- 10 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 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00559013
- Acronym / sponsor ID
- CP1011, Rev C
- Conditions
- Colorectal Cancer
- Keywords
- Staple line reinforcement, Staple line buttress, Anastomotic reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 24 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
Detailed description
Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Staple line reinforcementPSD Veritas Collagen Matrix Reinforcement Arm |
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 must comply with follow-up evaluations
- Patient or representative must provide informed consent prior to enrollment
- Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
- Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location
Key exclusion criteria (17 listed)
- Crohns disease
- Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
- Patients who have not had mechanical bowel preparation
- Patients with known documented sensitivity/allergy to bovine material
- Severe radiation damage to tissue
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 |
|---|---|---|
| Staple line reinforcementPlacement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery. | Device | 1 |
Primary outcome
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
Time frame: Discharge and 1 Month post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Richard Karulf, MD principal investigator
Colon & Rectal Surgery Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staple line reinforcement in people with Colorectal Cancer, run by Baxter Healthcare Corporation at 2 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 17 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 10 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 2 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?
Yes. Results are posted in the registry (first posted 24 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?
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. (time frame: Discharge and 1 Month post surgery). 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 10 May 2017.