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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Parotid Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Parotidectomy

Patients with an indication for surgical intervention for a parotidectomy.

Parotidectomy

Intervention Type PROCEDURE

Surgical Intervention with the FMwand Surgical System

Interventions

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Parotidectomy

Surgical Intervention with the FMwand Surgical System

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No