Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
1 other identifier
interventional
54
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 bariatric 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 Apr 2018
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
April 16, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2018
CompletedResults Posted
Study results publicly available
October 16, 2024
CompletedOctober 16, 2024
September 1, 2024
5 months
April 16, 2018
August 26, 2024
September 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
During planned bariatric procedure. (approximately 2 hours on a single day.)
Number of Participants With Adverse Events and Device Related Adverse Events
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Through 30 days post bariatric procedure
Study Arms (1)
Intervention
EXPERIMENTALLevita Magnetic Surgical System
Interventions
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- scheduled to undergo bariatric procedure
You may not qualify if:
- Am Soc Anesthesiology score of III or IV
- significant comorbidities
- subjects contraindicated for use of magnetic system
- clinical history of impaired coagulation
- hepatic abnormality or anatomical abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Levita Magneticslead
Study Sites (1)
Hospital La Florida
Santiago, Chile
Related Publications (1)
Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26.
PMID: 33011073DERIVED
Results Point of Contact
- Title
- Vivian Soto
- Organization
- Levita Magnetics
Study Officials
- PRINCIPAL INVESTIGATOR
Dana Portenier, MD
Duke Regional Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 26, 2018
Study Start
April 20, 2018
Primary Completion
September 6, 2018
Study Completion
September 6, 2018
Last Updated
October 16, 2024
Results First Posted
October 16, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share