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出境医 / 临床实验 / Study of Colorectal Procedures With the Levita Magnetic Surgical System

Study of Colorectal Procedures With the Levita Magnetic Surgical System

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 colorectal procedures.

Condition or disease Intervention/treatment Phase
Colorectal Procedures Device: Levita Magnetic Surgical System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Levita Magnetic Surgical System
Levita Magnetic Surgical System
 Device: Levita Magnetic Surgical System
Levita Magnetic Surgical System
Outcome Measures
Primary Outcome Measures :
  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.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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Chile
Hospital del Salvador
Santiago, Chile
Sponsors and Collaborators
Levita Magnetics
Investigators
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Principal Investigator: I. Emre Gorgun, MD The Cleveland Clinic
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • Device related Adverse events [ Time Frame: Through 30 days post prostatectomy procedure/study completion. ]
    All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Colorectal Procedures With the Levita Magnetic Surgical System
Official Title  ICMJE Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Procedures
Intervention  ICMJE Device: Levita Magnetic Surgical System
Levita Magnetic Surgical System
Study Arms  ICMJE Experimental: Levita Magnetic Surgical System
Levita Magnetic Surgical System
Intervention: Device: Levita Magnetic Surgical System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960684
Other Study ID Numbers  ICMJE CP006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Levita Magnetics
Study Sponsor  ICMJE Levita Magnetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: I. Emre Gorgun, MD The Cleveland Clinic
PRS Account Levita Magnetics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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