Trial Outcomes & Findings for Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery (NCT NCT03624465)

Last Updated: 2025-01-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

During planned prostatectomy procudure

Results posted on

2025-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	Levita Magnetic Surgical System Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levita Magnetic Surgical System n=30 Participants Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool.
Age, Continuous	65 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Chile	30 participants n=5 Participants

PRIMARY outcome

Timeframe: During planned prostatectomy procudure

Outcome measures

Outcome measures
Measure	Levita Magnetic Surgical System n=30 Participants Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool.
Number of Tools Required to Retract the Prostate During Procedure	0 Additional Tools to Mobilize Liver

PRIMARY outcome

Timeframe: Through 30 days post prostatectomy procedure.

All adverse events will be recorded and allocated as to relatedness to device, procedure or other.

Outcome measures

Outcome measures
Measure	Levita Magnetic Surgical System n=30 Participants Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool.
Incidence of Device Related Adverse Events (Safety)	0 Device Related AEs

Adverse Events

Levita Magnetic Surgical System

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levita Magnetic Surgical System n=30 participants at risk Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool.
Surgical and medical procedures Minor bleeding from surgical site on left flank	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
Surgical and medical procedures Ecchymosis in Assistant Port	10.0% 3/30 • Number of events 3 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
General disorders Chest Pain	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
General disorders Meatal Stenosis	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
Surgical and medical procedures Abdominal Wall Hematoma in Assistant Port Placement	6.7% 2/30 • Number of events 2 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
Surgical and medical procedures Ecchymosis Around Surgical Sites and Base of Penis Scrotum	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
General disorders Infected Pelvic Lymphoceles	3.3% 1/30 • Number of events 1 • Through 30 days post procedure. All adverse events were recorded and allocated as to relatedness to device, procedure, or other.

Additional Information

Vivian Soto

Levita Magnetics

Phone: +56958360507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place