Status:
COMPLETED
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Lead Sponsor:
Insightra Medical, Inc.
Conditions:
Inguinal Hernia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor v...
Detailed Description
The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the tw...
Eligibility Criteria
Inclusion
- Scheduled to undergo routine inguinal hernia repair
- Male and Female patients between 18 and 65 years old
- Competent to give consent
- Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- Primary hernia at the operative site
Exclusion
- Signs of obvious local or systemic infection
- Any previous surgery on the hernia operative site
- Hernia is not in the inguinal area
- Hernia is not identified as indirect or direct
- Femoral hernias
- Known collagen disorder
- Presenting with unstable angina or NYHA class of IV
- Known Pregnancy or Nursing women
- Active drug user
- Recurrence of a repair by any method
- Patients with giant inguinoscrotal hernia or abdominal wall defect \>35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
- Immunosuppression, prednisone\>15 mg/day, active chemotherapy
- End stage renal disease
- Abdominal ascites
- Skin infection in area of surgical field
- BMI \>35
- Peritoneum cannot be closed
- Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type)
- Neutropenia with absolute neutrophil count (ANC)\<500 cells/mm3
- Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure
- Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
- Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device
- Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
- Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
- Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02240550
Start Date
September 1 2014
End Date
December 1 2014
Last Update
January 18 2016
Active Locations (1)
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1
Healing Hands Clinic
Pune, India