Trial Outcomes & Findings for Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device (NCT NCT06432088)

NCT ID: NCT06432088

Last Updated: 2025-05-29

Results Overview

All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

30 days

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Extended Magnetic Grasper Device Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Magnetic Grasper Device n=30 Participants Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Chile	30 participants n=5 Participants
BMI	39.09 kg/m² STANDARD_DEVIATION 5.46 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.

Outcome measures

Outcome measures
Measure	Extended Magnetic Grasper Device n=30 Participants Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Number of Device Related Adverse Events	0 Device related adverse events

PRIMARY outcome

Timeframe: 1 day

Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.

Outcome measures

Outcome measures
Measure	Extended Magnetic Grasper Device n=30 Participants Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Mobilization Requiring Additional Retractors	0 Procedures w/ additional retractors

Adverse Events

Extended Magnetic Grasper Device

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Extended Magnetic Grasper Device n=30 participants at risk Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Extended Magnetic Grasper Device: The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Skin and subcutaneous tissue disorders Ecchymosis in Surgical Incision	16.7% 5/30 • Number of events 5 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Surgical and medical procedures Liver Capsule Minor Abrasion	16.7% 5/30 • Number of events 5 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Skin and subcutaneous tissue disorders Petechia	23.3% 7/30 • Number of events 7 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Cardiac disorders Sinus Tachycardia	3.3% 1/30 • Number of events 1 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Gastrointestinal disorders Transverse Colon Injury	3.3% 1/30 • Number of events 1 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
Cardiac disorders Atrioventricular Block	3.3% 1/30 • Number of events 1 • Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).

Additional Information

Vivian Soto

Levita Magnetics

Phone: +56958360507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place