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

January 23, 2016 updated by: Domain Surgical, Inc.
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00152
        • San Camillo-Forlanini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an indication for surgical intervention for a parotidectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parotidectomy
Patients with an indication for surgical intervention for a parotidectomy.
Procedure: Parotidectomy
Surgical Intervention with the FMwand Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
Time Frame: 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.
1 day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative drainiage
Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Evaluation of Post-operative Drainage
Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Swelling of surgical wound
Time Frame: 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
Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Necrosis of surgical margins
Time Frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Serosity and necrosis of margins
Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Length of hospital stay
Time Frame: 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
Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Domain Surgical, Inc.

Investigators

  • Principal Investigator: Bellocchi, MD, San Camillo-Forlanini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 23, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-IT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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