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

Domain Surgical

Status: Completed

Conditions: Parotid Diseases

Treatments: Procedure: Parotidectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT02291939

FMT-IT-01

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Parotidectomy

Description:

Patients with an indication for surgical intervention for a parotidectomy.

Treatment:

Procedure: Parotidectomy