Study of Colorectal Procedures With the Levita Magnetic Surgical System

Not Applicable

Completed

• Conditions: Colorectal Procedures

• Registration Number: NCT03960684
• Lead Sponsor: Levita Magnetics

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-06-25
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Results First Submitted: 2024-09-23
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Results First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues	During planned colorectal procedure	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.
Device Related Adverse Events	Through 30 days post colorectal procedure/study completion.	All adverse events will be recorded and allocated as to relatedness to device, procedure or other.

Trial Locations

Locations (1)

Hospital del Salvador; 🇨🇱 Santiago, Chile