Study of Surgical Mesh for Inguinal Hernia Repair

Biomerix

Status and phase

Unknown

Phase 4

Conditions

Hernia, Inguinal

Treatments

Device: Biomerix Revive™ (surgical mesh for inguinal hernia repair)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00924755

BMX-2008-03

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

Male

Ages

19+ years old

Volunteers

No Healthy Volunteers

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