Clinical trial NCT02291939: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
Official title: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parotid Diseases
Lead sponsor: Domain Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for surgical intervention for a parotidectomy.

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 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

Primary outcomes:
measure: Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Post-operative drainiage
timeFrame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
measure: Swelling of surgical wound
timeFrame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
measure: Necrosis of surgical margins
timeFrame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
measure: Length of hospital stay
timeFrame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Camillo-Forlanini Hospital
Study officials:
affiliation: San Camillo-Forlanini Hospital
name: Bellocchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowers CA, Burns G, Salzman KL, McGill LD, Macdonald JD. Comparison of tissue effects in rabbit muscle of surgical dissection devices. Int J Surg. 2014;12(3):219-23. doi: 10.1016/j.ijsu.2013.12.014. Epub 2014 Jan 7.
citation: Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
citation: MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014 Jun;44(6):1116-22. doi: 10.1007/s00595-013-0712-4. Epub 2013 Sep 5.