Status:
COMPLETED
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
Lead Sponsor:
Domain Surgical, Inc.
Conditions:
Parotid Diseases
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- Patients with an indication for surgical intervention for a parotidectomy.
- ECOG status ≤ 2.
- Life expectancy \> 3 months.
- Age ≥ 18 years old.
- Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study.
- Willingness to meet all of the expected requirements of this clinical protocol.
Exclusion
- Age \< 18 years old.
- Pregnant or breastfeeding.
- Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.).
- Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection.
- Previous radiation treatment
- Previous head or neck surgery
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02291939
Start Date
January 1 2015
End Date
December 1 2015
Last Update
January 26 2016
Active Locations (1)
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1
San Camillo-Forlanini Hospital
Roma, Italy, 00152