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OpenTrials
Completed

NCT Number: NCT03624465

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.

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Key information

Conditions

Prostatectomy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Arturo Lopez Perez (FALP)

Santiago, Chile

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levita Magnetic Surgical System

Device

Device for use as a surgical tool.

Primary outcomes

  1. Number of Tools Required to Retract the Prostate During Procedure

    Time frame: 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.

  2. Incidence of Device Related Adverse Events (Safety)

    Time frame: Through 30 days post prostatectomy procedure.

    All adverse events will be recorded and allocated as to relatedness to device, procedure or other.

Sponsors and collaborators

Lead sponsor

Levita Magnetics

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2018
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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