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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291939
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Parotid Diseases Procedure: Parotidectomy

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an indication for surgical intervention for a parotidectomy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291939


Locations
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Italy
San Camillo-Forlanini Hospital
Roma, Italy, 00152
Sponsors and Collaborators
Domain Surgical, Inc.
Investigators
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Principal Investigator: Bellocchi, MD San Camillo-Forlanini Hospital
Publications:
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Responsible Party: Domain Surgical, Inc.
ClinicalTrials.gov Identifier: NCT02291939    
Other Study ID Numbers: FMT-IT-01
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases