Parotid Diseases
Conditions
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.
Interventions
PROCEDUREParotidectomy
Surgical Intervention with the FMwand Surgical System
Sponsors
Domain Surgical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative drainiage | 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 | 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 | 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 | 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 |
Countries
Italy
Outcome results
None listed