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

NCT03624465 | Completed Results FDA Device

• 1 other identifier: CP005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Study Arms (1)

Levita Magnetic Surgical System

EXPERIMENTAL

Levita Magnetic Surgical System use of surgical tool

Device: Levita Magnetic Surgical System

Interventions

Levita Magnetic Surgical System DEVICE

Device for use as a surgical tool.

Levita Magnetic Surgical System

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age
• Subject is scheduled to undergo elective prostatectomy surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Levita Magnetics: lead

Study Sites (1)

Fundacion Arturo Lopez Perez (FALP)

Santiago, Chile

Location

Results Point of Contact

• Title: Vivian Soto
• Organization: Levita Magnetics

VSoto@Levita.com

+56958360507

Study Officials

• Matthew Gettman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: August 13, 2018
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: January 1, 2025
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)