Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
- Conditions
- Bariatric Surgery Candidate
- Interventions
- Device: Levita Magnetic Surgical System
- Registration Number
- NCT03508674
- 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 bariatric procedures
- Detailed Description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- at least 18 years of age
- scheduled to undergo bariatric procedure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Levita Magnetic Surgical System Levita Magnetic Surgical System
- Primary Outcome Measures
Name Time Method Number and Types of Additional Tools Required to Mobilize the Liver During Procedure During planned bariatric procedure. (approximately 2 hours on a single day.) 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.
Number of Participants With Adverse Events and Device Related Adverse Events Through 30 days post bariatric procedure All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital La Florida
🇨🇱Santiago, Chile