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Status unknownNCT00924755Updated Oct 4, 2010

Study of Surgical Mesh for Inguinal Hernia Repair

A Phase 4 interventional study of Biomerix Revive™ (surgical mesh for inguinal hernia repair) in Hernia, Inguinal, sponsored by Biomerix. Status unknown at 2 sites in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2010-10-04.

Sponsored by Biomerix · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
19 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Hernia, Inguinal

Keywords

  • Surgical mesh
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's planned enrollment of 25 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

This is the only study on the registry with Biomerix as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Interventions

  • DeviceBiomerix Revive™ (surgical mesh for inguinal hernia repair)

    Inguinal hernia repair using a tension-free onlay patch, Lichtenstein-style.

    Also known as: Revive

06

What researchers measure

Primary outcomes

  1. Technical success with no complications through 6 weeks.

    Time frame: 6 weeks

Secondary outcomes

  1. Hernia recurrence

    Time frame: 1 year

  2. Pain and functional status

    Time frame: 10 day, 6 weeks, 6 months 1 year

  3. Incidence of complications

    Time frame: 10 days, 6 weeks, 6 months, 1 year

07

Study locations

2 sites
  • Creighton University
    Omaha, Nebraska 68178, United States
  • Michael E. DeBakey Veterans Affairs Medical Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00924755
Lead sponsor
Biomerix
First posted
Jun 19, 2009
Start date
Jun 2009
Primary completion
Oct 2010 (estimated)
Completion
Nov 2010 (estimated)
Last update
Oct 4, 2010

Study contacts

Samir S Awad, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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