Study of Colorectal Procedures With the Levita Magnetic Surgical System

Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System

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

Study Overview

• Status: Completed
• Conditions: Colorectal Procedures
• Intervention / Treatment: Device: Levita Magnetic Surgical System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Hospital del Salvador

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is at least 18 years of age
• Subject is scheduled to undergo elective colorectal 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levita Magnetic Surgical System	Device: Levita Magnetic Surgical System; Levita Magnetic Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues	Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs 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 these tissues during the procedure. Cumulative number of additional tools required across all participants.	During planned colorectal procedure
Device Related Adverse Events	All adverse events will be recorded and allocated as to relatedness to device, procedure or other.	Through 30 days post colorectal procedure/study completion.

Collaborators and Investigators

• Sponsor: Levita Magnetics
• Investigators: Principal Investigator: I. Emre Gorgun, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CP006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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