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

Not Applicable

Completed

• Conditions: Prostatectomy
• Interventions: Device: Levita Magnetic Surgical System

• Registration Number: NCT03624465
• Lead Sponsor: Levita Magnetics

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.

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Study Start: 2018-08-13
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Results First Submitted: 2024-11-18
• Results First Submitted QC: 2024-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Results First Posted: 2024-12-12
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levita Magnetic Surgical System	Levita Magnetic Surgical System	Levita Magnetic Surgical System use of surgical tool

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fundacion Arturo Lopez Perez (FALP); 🇨🇱 Santiago, Chile