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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 vs. Lichtenstein inguinal hernia repair.

Detailed Summary:

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.


Sponsor: Insightra Medical, Inc.

Current Primary Outcome:

  • Evaluate the immediate and short-term amount of pain. [ Time Frame: 1 month ]
    We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
  • Compare the time required for return to normal activities (work). [ Time Frame: 1 month ]
    We will capture the time required to return to normal activities as indicated by the patient.


Original Primary Outcome: Same as current

Current Secondary Outcome: Identify any short-term related complication/adverse events associated with the procedures. [ Time Frame: 1 month ]

Original Secondary Outcome: Same as current

Information By: Insightra Medical, Inc.

Dates:
Date Received: September 8, 2014
Date Started: September 2014
Date Completion:
Last Updated: January 15, 2016
Last Verified: January 2016