Parotid DiseasesNCT02291939
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
An observational study of Parotid Diseases, run by Domain Surgical, Inc. at 1 site in Italy.
Trial summary
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head \& Neck surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Diseases
- What is being tested?
- Parotidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for surgical intervention for a parotidectomy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head \& Neck surgery.
- Conditions
- Parotid Diseases
- Being tested
- Parotidectomy
- Medical subject headings
- Parotid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParotidectomyProcedure or surgery
Surgical Intervention with the FMwand Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Parotidectomy | Patients with an indication for surgical intervention for a parotidectomy. Receives: Procedure: Parotidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System.
Measured: 1 day after surgery
Secondary outcomes (4)
Post-operative drainiage
Evaluation of Post-operative Drainage
Measured: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Swelling of surgical wound
Evaluation of surgical wound appearance based on swelling
Measured: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Necrosis of surgical margins
Serosity and necrosis of margins
Measured: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Length of hospital stay
Number of days (post-operative) of hospital stay
Measured: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parotid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Domain Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bellocchi, MD, Principal investigator, San Camillo-Forlanini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291939
- Sponsor's protocol ID
- FMT-IT-01
- Status last verified
- Jan 2016
- First submitted
- 4 Nov 2014
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bowers CA, Burns G, Salzman KL, McGill LD, Macdonald JD. Comparison of tissue effects in rabbit muscle of surgical dissection devices. Int J Surg. 2014;12(3):219-23. doi: 10.1016/j.ijsu.2013.12.014. Epub 2014 Jan 7.
PubMed 24406264Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014 Jun;44(6):1116-22. doi: 10.1007/s00595-013-0712-4. Epub 2013 Sep 5.
PubMed 24006128
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
- ClinicalTrials.gov ID
- NCT02291939
- Acronym / sponsor ID
- FMT-IT-01
- Conditions
- Parotid Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Domain Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head \& Neck surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parotidectomy | – | Procedure: ParotidectomyPatients with an indication for surgical intervention for a parotidectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for surgical intervention for a parotidectomy.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParotidectomySurgical Intervention with the FMwand Surgical System | Procedure or surgery | Parotidectomy |
Primary outcome
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.
4 secondary outcomes
Post-operative drainiage
Time frame: 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
Necrosis of surgical margins
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Background: PubMed 24406264Bowers CA, Burns G, Salzman KL, McGill LD, Macdonald JD. Comparison of tissue effects in rabbit muscle of surgical dissection devices. Int J Surg. 2014;12(3):219-23. doi: 10.1016/j.ijsu.2013.12.014. Epub 2014 Jan 7.
- BackgroundTok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation.
- Background: PubMed 24006128MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014 Jun;44(6):1116-22. doi: 10.1007/s00595-013-0712-4. Epub 2013 Sep 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bellocchi, MD principal investigator
San Camillo-Forlanini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parotid Diseases, run by Domain Surgical, Inc. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291939, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.