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

Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624465
• Other study ID #: CP005
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2024
• Source: Levita Magnetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatectomy

Intervention

Device:
• Levita Magnetic Surgical System
Device for use as a surgical tool.

Locations

Country	Name	City	State
Chile	Fundacion Arturo Lopez Perez (FALP)	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Levita Magnetics

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and types 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
Primary	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.