Clinical Trial: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

Brief Summary: The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.

Detailed Summary:
Sponsor: Domain Surgical, Inc.

Current Primary Outcome: Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility [ Time Frame: 1 day after surgery ]

Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Post-operative drainiage [ Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days ]
    Evaluation of Post-operative Drainage
  • Swelling of surgical wound [ Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days ]
    Evaluation of surgical wound appearance based on swelling
  • Necrosis of surgical margins [ Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days ]
    Serosity and necrosis of margins
  • Length of hospital stay [ Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days ]
    Number of days (post-operative) of hospital stay


Original Secondary Outcome: Same as current

Information By: Domain Surgical, Inc.

Dates:
Date Received: November 4, 2014
Date Started: January 2015
Date Completion:
Last Updated: January 23, 2016
Last Verified: January 2016