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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03624465
Other study ID # CP005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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