Bariatric Surgery Candidate
Conditions
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.
Interventions
use of surgical tool
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * scheduled to undergo bariatric procedure
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Levita Magnetic Surgical System
Levita Magnetic Surgical System: use of surgical tool | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 54 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 15 / 54 |
| serious Total, serious adverse events | 2 / 54 |
Outcome results
Primary
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.
Time frame: During planned bariatric procedure. (approximately 2 hours on a single day.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number and Types of Additional Tools Required to Mobilize the Liver During Procedure | 0 Additional Tools to Mobilize Liver |
Primary
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.
Time frame: Through 30 days post bariatric procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With Adverse Events and Device Related Adverse Events | Total Participants With Adverse Events | 17 participants |
| Intervention | Number of Participants With Adverse Events and Device Related Adverse Events | Participants With Adverse Events Related to Device | 14 participants |