Ventral Incisional HerniaCOBRANCT01325792
Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
An observational study of Ventral Incisional Hernia, run by W.L.Gore & Associates at 9 sites in 2 countries.
Trial summary
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Incisional Hernia
- What is being tested?
- GORE® BIO-A® Tissue Reinforcement
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2011to Dec 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: general and teaching hospitals
Who may be able to join
- Subjects will be informed about the study, and will have read; understood and signed the informed consent and authorization to use their PHI, as applicable
- Subjects willing and able to submit to postoperative follow-up evaluations including quality of life assessments up to 24 months after surgery
- Subjects of either gender that are at least the age of 18 years
- Subjects will have a Body-Mass Index (BMI) of < 40
- Subjects will be undergoing single-staged open complex ventral incisional hernia repair with the retrorectus or intraperitoneal placement technique of the GORE® BIO-A® Tissue Reinforcement
- Subjects in which intraoperatively their surgical field/wound is characterized either a Type 2 or Type 3 in Table 1 in Section 12.0
Show all 9Show fewer
- Subjects with a hernia defect > 9 cm2 large when measured intraoperatively
- Subjects in which the required mobility for midline fascial closure without excessive tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved
- Subjects in which one unit of GORE® BIO-A® Tissue Reinforcement will adequately reinforce the midline fascial closure with at least 4 cm of overlap laterally
Who cannot join
- Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
- Subjects with a BMI > 40
- Subjects with evidence of pre-existing systemic infections
- Subjects with cirrhosis or are currently being treated with dialysis
- Subjects with a wound-healing disorder
- Subjects with autoimmune disorder requiring > 10mg of a corticosteroid per day
Show all 16Show fewer
- Subjects who are immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy
- Subjects with a hernia defect < 9 cm2 large when measured intraoperatively
- Subjects with a hernia defect requiring more than one unit of GORE® BIO-A® Tissue Reinforcement
- Subjects in which intraoperatively there is an inability to achieve retrorectus or intraperitoneal placement of the device
- Subjects in which a midline fascial closure without excessive tension cannot be achieved
- Subjects in which intraoperatively their surgical field/wound is characterized either a Type 1 or Type 4 in the Table 1 in Section 12
- Subjects in need of concomitant surgical procedures other than indicated in the protocol as acceptable
- Subject in which their complex ventral incisional hernia repair requires more than one operation to reduce hernia and close fascia, including serial excision procedures - requiring subsequent surgery to complete their hernia repair
- Subjects with a hernia repair requiring an emergent procedure, such as strangulated bowel
- Subjects in which intraoperatively untreated cancer was found
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Case Medical Center, Case Western Reserve University, Case Western Reserve University
Cleveland, Ohio, 44106
Greenville Hospital System
Greenville, South Carolina, 29607
Indiana University
Indianapolis, Indiana, 46202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Medical Center
New York, New York, 10021
UCSD Department of Surgery
San Diego, California, 92103
Washington University
St Louis, Missouri, 63110
Netherlands1 site
Canisius-Wilhelmina Ziekenhuis
Nijmegen, The Netherlands
About this study
Official title: Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
Read the detailed description
The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.
- Conditions
- Ventral Incisional Hernia
- Being tested
- GORE® BIO-A® Tissue Reinforcement
- Keywords
- Complex ventral incisional hernia repair, reapproximation of the rectus abdominis muscle, retrorectus or intraperitoneal placement technique, mobility for midline fascial closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® BIO-A® Tissue ReinforcementDevice
Also called Biosynthetic Mesh
Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
| Study group | Role | What they receive |
|---|---|---|
| GORE® BIO-A® Tissue Reinforcement | Single-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia. Receives: Device: GORE® BIO-A® Tissue Reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence Rate
Investigator confirmed hernia recurrence by physical examination
Measured: at about 24 months
Secondary outcomes (1)
Early and Long-term Complication Rates
Surgical site abdominal wound event rate
Measured: after surgery (day 1) to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
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 Ventral Incisional HerniaStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Rosen, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325792
- Sponsor's protocol ID
- CS155
- Acronym
- COBRA
- Status last verified
- Nov 2015
- First submitted
- 28 Mar 2011
- Last updated
- 24 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement
- ClinicalTrials.gov ID
- NCT01325792
- Acronym / sponsor ID
- COBRA / CS155
- Conditions
- Ventral Incisional Hernia
- Keywords
- Complex ventral incisional hernia repair, reapproximation of the rectus abdominis muscle, retrorectus or intraperitoneal placement technique, mobility for midline fascial closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Posted 24 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
Detailed description
The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® BIO-A® Tissue Reinforcement | – | Device: GORE® BIO-A® Tissue ReinforcementSingle-staged open complex ventral incisional repair of primary or recurrent anterior abdominal wall hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general and teaching hospitals
Key inclusion criteria (9 listed)
- Subjects will be informed about the study, and will have read; understood and signed the informed consent and authorization to use their PHI, as applicable
- Subjects willing and able to submit to postoperative follow-up evaluations including quality of life assessments up to 24 months after surgery
- Subjects of either gender that are at least the age of 18 years
- Subjects will have a Body-Mass Index (BMI) of < 40
- Subjects will be undergoing single-staged open complex ventral incisional hernia repair with the retrorectus or intraperitoneal placement technique of the GORE® BIO-A® Tissue Reinforcement
Key exclusion criteria (16 listed)
- Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
- Subjects with a BMI > 40
- Subjects with evidence of pre-existing systemic infections
- Subjects with cirrhosis or are currently being treated with dialysis
- Subjects with a wound-healing disorder
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 |
|---|---|---|
| GORE® BIO-A® Tissue ReinforcementAlso: Biosynthetic MeshRetrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia. | Device | GORE® BIO-A® Tissue Reinforcement |
Primary outcome
Hernia Recurrence Rate
Time frame: at about 24 months
Investigator confirmed hernia recurrence by physical examination
1 secondary outcome
Early and Long-term Complication Rates
Time frame: after surgery (day 1) to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventral Incisional Hernia
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Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
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The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
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Cryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair
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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.
Michael Rosen, MD principal investigator
University Hospitals Cleveland Medical Center
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Incisional Hernia, run by W.L.Gore & Associates at 9 sites in 2 countries.
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 9 inclusion and 16 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Netherlands. 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 Dec 2015). 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?
Hernia Recurrence Rate (time frame: at about 24 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 24 Dec 2015; AzTrials last refreshed its copy on 29 Oct 2026.