Back to resultsStudy of Surgical Mesh for Inguinal Hernia Repair
Primary Purpose
Hernia, Inguinal
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Biomerix Revive™ (surgical mesh for inguinal hernia repair)
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring Surgical mesh
Eligibility 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
Sites / Locations
- Creighton University
- Michael E. DeBakey Veterans Affairs Medical Center
Outcomes
Primary Outcome Measures
Technical success with no complications through 6 weeks.
Secondary Outcome Measures
Hernia recurrence
Pain and functional status
Incidence of complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00924755
Brief Title
Study of Surgical Mesh for Inguinal Hernia Repair
Official Title
Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Biomerix
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Surgical mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Biomerix Revive™ (surgical mesh for inguinal hernia repair)
Other Intervention Name(s)
Revive
Intervention Description
Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.
Primary Outcome Measure Information:
Title
Technical success with no complications through 6 weeks.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hernia recurrence
Time Frame
1 year
Title
Pain and functional status
Time Frame
10 day, 6 weeks, 6 months 1 year
Title
Incidence of complications
Time Frame
10 days, 6 weeks, 6 months, 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir S Awad, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Surgical Mesh for Inguinal Hernia Repair
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