Prostatectomy
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.
Detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.
Interventions
Device for use as a surgical tool.
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age * Subject is scheduled to undergo elective prostatectomy surgery
Exclusion criteria
* Significant comorbidities * Subjects with pacemakers, defibrillators, or other electromedical implants * Subjects with ferromagnetic implants * Clinical history of impaired coagulation * Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use * Subject is not likely to comply with the follow-up evaluation schedule * Subject is participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tools Required to Retract the Prostate During Procedure | During planned prostatectomy procudure | Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure. |
| Incidence of Device Related Adverse Events (Safety) | Through 30 days post prostatectomy procedure. | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levita Magnetic Surgical System Levita Magnetic Surgical System use of surgical tool
Levita Magnetic Surgical System: Device for use as a surgical tool. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Levita Magnetic Surgical System |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Incidence of Device Related Adverse Events (Safety)
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Time frame: Through 30 days post prostatectomy procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Magnetic Surgical System | Incidence of Device Related Adverse Events (Safety) | 0 Device Related AEs |
Primary
Number of Tools Required to Retract the Prostate During Procedure
Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure.
Time frame: During planned prostatectomy procudure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Magnetic Surgical System | Number of Tools Required to Retract the Prostate During Procedure | 0 Additional Tools to Mobilize Liver |