An interventional study of Levita Magnetic Surgical System in Prostatectomy, sponsored by Levita Magnetics. Completed at 1 site in Chile. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by Levita Magnetics · Not applicable, Interventional, and Other
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.
Levita Magnetics is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Levita Magnetic Surgical System use of surgical tool
Device: Levita Magnetic Surgical System
Device for use as a surgical tool.
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
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.
| Milestone | Levita Magnetic Surgical System |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| Additional Tools to Mobilize Liver | Levita Magnetic Surgical System |
|---|---|
| Number of Tools Required to Retract the Prostate During Procedure | 0 |
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
| Device Related AEs | Levita Magnetic Surgical System |
|---|---|
| Incidence of Device Related Adverse Events (Safety) | 0 |
Collected over Through 30 days post procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levita Magnetic Surgical System | 0/30 (0%) | 0/30 (0%) | 10/30 (33.3%) |
| Event | Levita Magnetic Surgical System |
|---|---|
| Ecchymosis in Assistant PortSurgical and medical procedures | 3/30 |
| Abdominal Wall Hematoma in Assistant Port PlacementSurgical and medical procedures | 2/30 |
| Minor bleeding from surgical site on left flankSurgical and medical procedures | 1/30 |
| Chest PainGeneral disorders | 1/30 |
| Meatal StenosisGeneral disorders | 1/30 |
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 1/30 |
| Ecchymosis Around Surgical Sites and Base of Penis ScrotumSurgical and medical procedures | 1/30 |
| Infected Pelvic LymphocelesGeneral disorders | 1/30 |
| Age, Continuous(years) | Levita Magnetic Surgical System |
|---|---|
| Mean | 65 ± 7.3 |
| Sex: Female, Male(Participants) | Levita Magnetic Surgical System |
|---|---|
| Female | 0 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | Levita Magnetic Surgical System |
|---|---|
| Hispanic or Latino | 30 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Levita Magnetic Surgical System |
|---|---|
| Chile | 30 |
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Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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