Study of Surgical Mesh for Inguinal Hernia Repair
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Biomerix.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Biomerix
Information provided by:
Biomerix
ClinicalTrials.gov Identifier:
NCT00924755
First received: June 17, 2009
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hernia, Inguinal |
Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique |
Resource links provided by NLM:
Further study details as provided by Biomerix:
Primary Outcome Measures:
- Technical success with no complications through 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hernia recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Pain and functional status [ Time Frame: 10 day, 6 weeks, 6 months 1 year ] [ Designated as safety issue: No ]
- Incidence of complications [ Time Frame: 10 days, 6 weeks, 6 months, 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)
Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
Other Name: Revive
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924755
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924755
Locations
| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68178 | |
| United States, Texas | |
| Michael E. DeBakey Veterans Affairs Medical Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Biomerix
Investigators
| Principal Investigator: | Samir S Awad, MD | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Christina Kichula, Biomerix |
| ClinicalTrials.gov Identifier: | NCT00924755 History of Changes |
| Other Study ID Numbers: | BMX-2008-03 |
| Study First Received: | June 17, 2009 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomerix:
|
Surgical mesh |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Hernia, Abdominal Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on February 27, 2015