Study of Colorectal Procedures With the Levita Magnetic Surgical System
Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2019
CompletedResults Posted
Study results publicly available
December 5, 2024
CompletedDecember 5, 2024
November 1, 2024
6 months
May 20, 2019
September 23, 2024
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (1)
Levita Magnetic Surgical System
EXPERIMENTALLevita Magnetic Surgical System
Interventions
Eligibility Criteria
You may qualify if:
- Subject is at least 18 years of age
- Subject is scheduled to undergo elective colorectal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Levita Magneticslead
Study Sites (1)
Hospital del Salvador
Santiago, Chile
Results Point of Contact
- Title
- Vivian Soto
- Organization
- Levita Magnetics
Study Officials
- PRINCIPAL INVESTIGATOR
I. Emre Gorgun, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 23, 2019
Study Start
June 25, 2019
Primary Completion
December 9, 2019
Study Completion
December 9, 2019
Last Updated
December 5, 2024
Results First Posted
December 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share