HerniaXenMatrixNCT01305486
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
An observational study of Hernia, run by C. R. Bard at 1 site in United States.
Trial summary
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are diagnosed with a ventral or incisional hernia that require a component separation repair with the use of a biological graft.
Who may be able to join
- Be able to undergo study procedures.
- Have signed an Informed Consent form (ICF).
- Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
- Requires a component separation repair with the use of a biological graft.
Who cannot join
- Subject is participating in another device or drug study.
- Subject has a life expectancy less than 4 years at the time of enrollment.
- Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
- Any subject with a defect the surgeon feels he/she cannot fully close.
- Subjects with a BMI > 50.
- Subjects with connective tissue disorders.
Show all 13Show fewer
- Subjects with a history of cirrhosis.
- Subjects with renal failure requiring dialysis.
- Subjects on or suspected to be placed on chemotherapy or systemic immunosuppressive medications during any part of the study.
- Transplant recipients.
- Subjects taking corticosteroids for >6 months (pre or post surgery).
- Any bowel leak or infection that would preclude the use of the XenMatrix™ Surgical Graft in the opinion of the investigator.
- The subject lives approximately 2 hours away from the study site and compliance with follow up requirements will be difficult in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.
- Conditions
- Hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| XenMatrix | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery.
Any hernia which is identified or confirmed by the investigator in approximately the same position as the hernia repair during any follow up visit after a XenMatrix™ surgical graft has been placed will be considered a recurrent hernia.
Measured: 2 Years
Secondary outcomes (4)
To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.
Procedural and device related AEs collected from surgery until 24 months post surgery.
Measured: 2 Years
To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.
Procedure time will be defined as beginning when the investigator makes the initial skin incision and ending when the skin closure is completed (skin to skin).
Measured: Day 0
To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.
Changes in QOL will be assessed from baseline to 24 months utilizing the Short Form-36 (SF-36) version 2.
Measured: 2 years
To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.
Subjects who have their grafts placed in different tissue planes will have their recurrence rate, complication type and frequency examined to determine if there are any gross differences.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Sponsor decision, not safety related.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl LeBlanc, MD, Principal investigator, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305486
- Sponsor's protocol ID
- DVL-HE008
- Acronym
- XenMatrix
- Status last verified
- Jan 2013
- First submitted
- 22 Dec 2010
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
- ClinicalTrials.gov ID
- NCT01305486
- Acronym / sponsor ID
- XenMatrix / DVL-HE008
- Conditions
- Hernia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision, not safety related.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Feb 2011 (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 will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XenMatrix | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are diagnosed with a ventral or incisional hernia that require a component separation repair with the use of a biological graft.
Key inclusion criteria (4 listed)
- Be able to undergo study procedures.
- Have signed an Informed Consent form (ICF).
- Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
- Requires a component separation repair with the use of a biological graft.
Key exclusion criteria (13 listed)
- Subject is participating in another device or drug study.
- Subject has a life expectancy less than 4 years at the time of enrollment.
- Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
- Any subject with a defect the surgeon feels he/she cannot fully close.
- Subjects with a BMI > 50.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery.
Time frame: 2 Years
Any hernia which is identified or confirmed by the investigator in approximately the same position as the hernia repair during any follow up visit after a XenMatrix™ surgical graft has been placed will be considered a recurrent hernia.
4 secondary outcomes
To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.
Time frame: 2 Years
To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.
Time frame: Day 0
To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.
Time frame: 2 years
To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision, not safety related.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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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.
Karl LeBlanc, MD principal investigator
Our Lady of the Lake Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by C. R. Bard 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 13 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: stopped early, as of the sponsor's last update on 15 Jan 2013. 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?
The study was stopped early (reason given: Sponsor decision, not safety related.). Results are not available in the source record.
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?
To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery. (time frame: 2 Years). 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 15 Jan 2013.