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 ]
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