Trial Outcomes & Findings for Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System (NCT NCT03508674)
NCT ID: NCT03508674
Last Updated: 2024-10-16
Results Overview
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.
COMPLETED
NA
54 participants
During planned bariatric procedure. (approximately 2 hours on a single day.)
2024-10-16
Participant Flow
Participant milestones
| Measure |
Intervention
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
Baseline characteristics by cohort
| Measure |
Intervention
n=54 Participants
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Chile
|
54 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=54 Participants
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
|
0 Additional Tools to Mobilize Liver
|
PRIMARY outcome
Timeframe: Through 30 days post bariatric procedureAll adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Outcome measures
| Measure |
Intervention
n=54 Participants
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Number of Participants With Adverse Events and Device Related Adverse Events
Participants With Adverse Events Related to Device
|
14 participants
|
|
Number of Participants With Adverse Events and Device Related Adverse Events
Total Participants With Adverse Events
|
17 participants
|
Adverse Events
Intervention
Serious adverse events
| Measure |
Intervention
n=54 participants at risk
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
1.9%
1/54 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Abdominal Pain and Vomiting
|
1.9%
1/54 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Intervention
n=54 participants at risk
Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool
|
|---|---|
|
Skin and subcutaneous tissue disorders
Petechiae
|
14.8%
8/54 • Number of events 8 • 30 days
|
|
Hepatobiliary disorders
Liver Capsule Superficial Erosion Without Bleeding
|
13.0%
7/54 • Number of events 7 • 30 days
|
|
Hepatobiliary disorders
Liver Capsule Superficial Abrasion Without Bleeding
|
3.7%
2/54 • Number of events 2 • 30 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.7%
2/54 • Number of events 2 • 30 days
|
|
Hepatobiliary disorders
Hepatic Hematoma
|
1.9%
1/54 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
1.9%
1/54 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place