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

Completed

• Conditions: Parotid Diseases
• Interventions: Procedure: Parotidectomy

• Registration Number: NCT02291939
• Lead Sponsor: Domain Surgical, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-23
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parotidectomy	Parotidectomy	Patients with an indication for surgical intervention for a parotidectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

San Camillo-Forlanini Hospital; 🇮🇹 Roma, Italy