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OpenTrials
Completed

NCT Number: NCT03960684

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.

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Key information

Conditions

Colorectal Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Salvador

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 colorectal procedures.

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 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

Treatment and study plan

Levita Magnetic Surgical System

Device

Levita Magnetic Surgical System

Primary outcomes

  1. Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues

    Time frame: 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.

  2. Device Related Adverse Events

    Time frame: Through 30 days post colorectal procedure/study completion.

    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

Official study title

Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 23, 2019
Registry last updated
Dec 5, 2024

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.