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

Levita Magnetics

Status: Completed

Conditions: Prostatectomy

Treatments: Device: Levita Magnetic Surgical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624465

CP005

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Levita Magnetic Surgical System

Experimental group

Description:

Levita Magnetic Surgical System use of surgical tool

Treatment:

Device: Levita Magnetic Surgical System