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

• Sponsor: Levita Magnetics (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03624465
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatectomy	Device: Levita Magnetic Surgical System	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
• Actual Study Start Date: Aug 13, 2018
• Anticipated Primary Completion Date: May 30, 2019
• Anticipated Study Completion Date: Jul 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levita Magnetic Surgical System Levita Magnetic Surgical System use of surgical tool	Device: Levita Magnetic Surgical System; Device for use as a surgical tool.

Outcome Measures

Primary Outcome Measures

1. Number and types 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Arturo Lopez Perez (FALP)	Santiago		Chile

Sponsors and Collaborators

• Levita Magnetics

Investigators

• Principal Investigator: Matthew Gettman, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Levita Magnetics
• ClinicalTrials.gov Identifier: NCT03624465
• Other Study ID Numbers: CP005
• First Posted: Aug 10, 2018
• Last Update Posted: Jun 5, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jun 5, 2019