Trial Outcomes & Findings for Levita Magnetic Grasper Device Safety and Performance Study (NCT NCT02049983)

Last Updated: 2024-09-25

Results Overview

Absence of any damage or side effect to the patient directly produced by the device during the surgery

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

During surgery

Results posted on

2024-09-25

Participant milestones
Measure	Use of Levita Magnetics Grasper Use of Levita Magnetics Grasper
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Levita Magnetic Grasper Device Safety and Performance Study

Baseline characteristics by cohort
Measure	Use of Levita Magnetics Grasper n=50 Participants Use of Levita Magnetics Grasper
Age, Continuous	39 years STANDARD_DEVIATION 12.4 • n=99 Participants
Sex: Female, Male Female	45 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment Chile	50 participants n=99 Participants
BMI	27.0 kg/m squared STANDARD_DEVIATION 3.6 • n=99 Participants
Indication for surgery Gallbladder stones	43 participants n=99 Participants
Indication for surgery Gallbladder polyps	7 participants n=99 Participants
Ultrasound assessment of gallbladder thickness	1.8 mm STANDARD_DEVIATION 0.5 • n=99 Participants
Ultrasound assessment of abdominal wall thickness	2.6 cm STANDARD_DEVIATION 0.6 • n=99 Participants

Timeframe: During surgery

Absence of any damage or side effect to the patient directly produced by the device during the surgery

Outcome measures
Measure	Use of Levita Magnetics Grasper n=50 Participants Use of Levita Magnetics Grasper
Safety Assessment of AEs No device related adverse events	50 Participants
Safety Assessment of AEs Device related adverse events	0 Participants

Timeframe: Intra-operative

Ability to adequately mobilize the organ during the surgery

Outcome measures
Measure	Use of Levita Magnetics Grasper n=50 Participants Use of Levita Magnetics Grasper
Feasibility of Mobilization Organ adequately mobilized	50 Participants
Feasibility of Mobilization Excellent quality of exposure	45 Participants
Feasibility of Mobilization Sufficient quality of exposure	5 Participants
Feasibility of Mobilization Insufficient quality of exposure	0 Participants

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events
Measure	Use of Levita Magnetics Grasper n=50 participants at risk Use of Levita Magnetics Grasper
Skin and subcutaneous tissue disorders hematoma (sub capsular)	2.0% 1/50 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders subcutaneous emphysema	2.0% 1/50 • Number of events 1 • 30 days
Gastrointestinal disorders extrahepatic biloma	2.0% 1/50 • Number of events 1 • 30 days

Other adverse events
Measure	Use of Levita Magnetics Grasper n=50 participants at risk Use of Levita Magnetics Grasper
Skin and subcutaneous tissue disorders petechiae, internal	38.0% 19/50 • Number of events 19 • 30 days
Skin and subcutaneous tissue disorders petechiae, external	2.0% 1/50 • 30 days

Levita Magnetics International Corp

Phone: 6506557625