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OpenTrials
Completed

NCT Number: NCT02291939

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

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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Key information

Conditions

Parotid Diseases Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Camillo-Forlanini Hospital

Roma, 00152, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parotidectomy

Procedure

Surgical Intervention with the FMwand Surgical System

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Domain Surgical, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2014
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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