Inguinal HerniaNCT00393887
Inguinal Hernia Study Using Biodesign IHM
A study testing Biodesign IHM and Polypropylene mesh in people with Inguinal Hernia, run by Cook Group Incorporated at 1 site in United States.
Trial summary
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Biodesign IHM and Polypropylene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2014
- 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
- 18 years of age
- Diagnosis of Unilateral inguinal hernia repair
- Able to provide written consent
Who cannot join
- Incarcerated hernia
- Allergic or religious beliefs that disallow porcine material
- Previous hernia repair on the designated hernia site
- Class IV or V anesthesia requirements
- Bowel obstruction
- Peritonitis
- Life expectancy < 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
- Conditions
- Inguinal Hernia
- Being tested
- Biodesign IHM, Polypropylene mesh
- Keywords
- Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign IHMDevice
Also called SurgiSIS IHM
Biodesign IHM is placed to reinforce the hernia repair
Polypropylene meshDevice
Polypropylene mesh is used to reinforce the hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Biodesign IHM Graft placement Receives: Device: Biodesign IHM |
| 2 | Active comparator | Polypropylene mesh placement Receives: Device: Polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Inguinal Hernia Recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startMar 2007
- Primary completionJun 2014
- Study completionJun 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 Inguinal HerniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, MED Institute, Incorporated
- Responsible party
- Sponsor
- Investigators
- Tracy Timmons, M.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393887
- Sponsor's protocol ID
- H-28044
- Other IDs
- 05-003
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2006
- Last updated
- 20 Nov 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 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00393887
- Acronym / sponsor ID
- H-28044
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, MED Institute, Incorporated
- Study start
- Mar 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Posted 25 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Biodesign IHMBiodesign IHM Graft placement |
| 2 | Active comparator | Device: Polypropylene meshPolypropylene mesh placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- Diagnosis of Unilateral inguinal hernia repair
- Able to provide written consent
Key exclusion criteria (7 listed)
- Incarcerated hernia
- Allergic or religious beliefs that disallow porcine material
- Previous hernia repair on the designated hernia site
- Class IV or V anesthesia requirements
- Bowel obstruction
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 |
|---|---|---|
| Biodesign IHMAlso: SurgiSIS IHMBiodesign IHM is placed to reinforce the hernia repair | Device | 1 |
| Polypropylene meshPolypropylene mesh is used to reinforce the hernia repair. | Device | 2 |
Primary outcome
Number of Patients With Inguinal Hernia Recurrence
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Biologic vs Synthetic Inguinal Hernia Repair: 1-year Results of a Randomized Double-Blinded TrialLink provided by the sponsor.
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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.
Tracy Timmons, M.D. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodesign IHM and Polypropylene mesh in people with Inguinal Hernia, run by Cook Group Incorporated 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 3 inclusion and 7 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 20 Nov 2015. 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 25 Aug 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?
Number of Patients With Inguinal Hernia Recurrence (time frame: 1 year). 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 20 Nov 2015.