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

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.

Study Overview

• Status: Completed
• Conditions: Prostatectomy
• Intervention / Treatment: Device: Levita Magnetic Surgical System

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Fundación Arturo López Pérez (FALP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levita Magnetic Surgical System; Levita Magnetic Surgical System use of surgical tool	Device: Levita Magnetic Surgical System; Device for use as a surgical tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Device Related Adverse Events (Safety)	All adverse events will be recorded and allocated as to relatedness to device, procedure or other.	Through 30 days post prostatectomy procedure.
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.	During planned prostatectomy procudure

Collaborators and Investigators

• Sponsor: Levita Magnetics
• Investigators: Principal Investigator: Matthew Gettman, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CP005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes