Colorectal Procedures
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
Detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in colorectal procedures.
Interventions
Levita Magnetic Surgical System
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age * Subject is scheduled to undergo elective colorectal surgery
Exclusion criteria
* Significant comorbidities * Subjects with pacemakers, defibrillators, or other electromedical implants * Subjects with ferromagnetic implants * Clinical history of impaired coagulation * Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use * Subject is not likely to comply with the follow-up evaluation schedule * Subject is participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues | During planned colorectal procedure | Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract these tissues during the procedure. Cumulative number of additional tools required across all participants. |
| Device Related Adverse Events | Through 30 days post colorectal procedure/study completion. | 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 |
|---|---|
| Levita Magnetic Surgical System Levita Magnetic Surgical System | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not proceed to surgery with MSS | 1 |
Baseline characteristics
| Characteristic | Levita Magnetic Surgical System |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Chile | 31 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 6 / 30 |
| serious Total, serious adverse events | 4 / 30 |
Outcome results
Primary
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 colorectal procedure/study completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Magnetic Surgical System | Device Related Adverse Events | 6 Number of Device Related Adverse Events |
Primary
Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues
Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract these tissues during the procedure. Cumulative number of additional tools required across all participants.
Time frame: During planned colorectal procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levita Magnetic Surgical System | Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues | 0 Cumulative number of additional tools |