Hernia, InguinalPhase 4NCT00924755
Study of Surgical Mesh for Inguinal Hernia Repair
A Phase 4 study testing Biomerix Revive™ (surgical mesh for inguinal hernia repair) in people with Hernia, Inguinal, run by Biomerix at 2 sites in United States.
Trial summary
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Biomerix Revive™ (surgical mesh for inguinal hernia repair)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Nov 2010
- Phase
- Phase 4
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male ≥19 years old
- symptomatic and palpable inguinal hernia
- candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
- will comply with required follow-up study visits
- willing and able to provide written informed consent
Who cannot join
- BMI ≥35
- life expectancy of <3 years
- strangulated hernia
- urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
- active abdominal surgical condition such as bowel obstruction or perforation
- local or systemic infection or peritonitis
Show all 19Show fewer
- known disease that impairs wound healing
- anti-platelet therapy (other than aspirin) for >7 days preceding the surgical procedure
- previous ipsilateral groin incision
- receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
- uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
- advanced cirrhosis with Child-Turcott Class of C or higher
- severe COPD requiring home oxygen
- diagnosed with chronic pain syndrome or is undergoing treatment for pain management
- candidate for another major surgical procedure with the inguinal hernia repair
- enrolled in another investigational study that may confound the results of this study
- known drug abuser
- on anti-psychotic medications
- Worker's Compensation case
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
Creighton University
Omaha, Nebraska, 68178
About this study
Official title: Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.
- Conditions
- Hernia, Inguinal
- Being tested
- Biomerix Revive™ (surgical mesh for inguinal hernia repair)
- Keywords
- Surgical mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomerix Revive™ (surgical mesh for inguinal hernia repair)Device
Also called Revive
Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success with no complications through 6 weeks.
Measured: 6 weeks
Secondary outcomes (3)
Hernia recurrence
Measured: 1 year
Pain and functional status
Measured: 10 day, 6 weeks, 6 months 1 year
Incidence of complications
Measured: 10 days, 6 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomerix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Samir S Awad, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924755
- Sponsor's protocol ID
- BMX-2008-03
- Status last verified
- Oct 2010
- First submitted
- 17 Jun 2009
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
- ClinicalTrials.gov ID
- NCT00924755
- Acronym / sponsor ID
- BMX-2008-03
- Conditions
- Hernia, Inguinal
- Keywords
- Surgical mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- BiomerixIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 19 Jun 2009 (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.
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male ≥19 years old
- symptomatic and palpable inguinal hernia
- candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
- will comply with required follow-up study visits
- willing and able to provide written informed consent
Key exclusion criteria (19 listed)
- BMI ≥35
- life expectancy of <3 years
- strangulated hernia
- urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
- active abdominal surgical condition such as bowel obstruction or perforation
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 |
|---|---|---|
| Biomerix Revive™ (surgical mesh for inguinal hernia repair)Also: ReviveInguinal hernia repair using a tension-free onlay patch, Lichtenstein-style. | Device | – |
Primary outcome
Technical success with no complications through 6 weeks.
Time frame: 6 weeks
3 secondary outcomes
Hernia recurrence
Time frame: 1 year
Pain and functional status
Time frame: 10 day, 6 weeks, 6 months 1 year
Incidence of complications
Time frame: 10 days, 6 weeks, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
Related trials for Hernia, Inguinal
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Samir S Awad, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biomerix Revive™ (surgical mesh for inguinal hernia repair) in people with Hernia, Inguinal, run by Biomerix 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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 4 Oct 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Technical success with no complications through 6 weeks. (time frame: 6 weeks). 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 4 Oct 2010.