Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parotidectomy | Patients with an indication for surgical intervention for a parotidectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parotidectomy | Procedure | Surgical Intervention with the FMwand Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative drainiage | 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 | Evaluation of surgical wound appearance based on swelling |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with an indication for surgical intervention for a parotidectomy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bellocchi, MD | San Camillo-Forlanini Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Camillo-Forlanini Hospital | Roma | 00152 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24406264 | Background | 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. | |
| Background | Tok, S et al. Comparison of a Novel Thermal Surgical Technology with Monopolar and Carbon Dioxide Laser in a Rat Glioma Model. Poster presentation. | ||
| 24006128 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010305 | Parotid Diseases |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days |
| Background |
| 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. |