NCT02240550

A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Insightra Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 vs. Lichtenstein inguinal hernia repair.

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 two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives. The secondary objective of the study is to identify any short-term study related complications/adverse events. The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone. Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	ProFlor Hernia Repair System	The 3-D hernia mesh will be used in the repair of your inguinal hernia.
DEVICE	Lichtenstein hernia repair	The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-09-15
• Last updated: 2016-01-18

Locations

1 site across 1 country: India