Trial Outcomes & Findings for Study of Colorectal Procedures With the Levita Magnetic Surgical System (NCT NCT03960684)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

During planned colorectal procedure

Results posted on

2024-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Levita Magnetic Surgical System Levita Magnetic Surgical System
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Levita Magnetic Surgical System Levita Magnetic Surgical System
Overall Study Did not proceed to surgery with MSS	1

Baseline Characteristics

1 subject did not proceed with procedure. Data was not analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levita Magnetic Surgical System n=31 Participants Levita Magnetic Surgical System
Age, Continuous	63 years STANDARD_DEVIATION 16.8 • n=30 Participants • 1 subject did not proceed with procedure. Data was not analyzed.
Sex: Female, Male Female	15 Participants n=30 Participants • 1 subject did not proceed with procedure and data was not analyzed.
Sex: Female, Male Male	15 Participants n=30 Participants • 1 subject did not proceed with procedure and data was not analyzed.
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=30 Participants • 1 subject did not proceed with procedure. Data was not analyzed.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=30 Participants • 1 subject did not proceed with procedure. Data was not analyzed.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants • 1 subject did not proceed with procedure. Data was not analyzed.
Region of Enrollment Chile	31 participants n=31 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Levita Magnetic Surgical System n=30 Participants Levita Magnetic Surgical System
Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues	0 Cumulative number of additional tools

PRIMARY outcome

Timeframe: Through 30 days post colorectal procedure/study completion.

All adverse events will be recorded and allocated as to relatedness to device, procedure or other.

Outcome measures

Outcome measures
Measure	Levita Magnetic Surgical System n=30 Participants Levita Magnetic Surgical System
Device Related Adverse Events	6 Number of Device Related Adverse Events

Adverse Events

Levita Magnetic Surgical System

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Levita Magnetic Surgical System n=30 participants at risk Levita Magnetic Surgical System
Gastrointestinal disorders Dehiscence Colorectal Anastomosis	3.3% 1/30 • Number of events 1 • 30 days post-procedure
Gastrointestinal disorders Pelvic Fluid Collection in Relation to Ileal Pouch	3.3% 1/30 • Number of events 1 • 30 days post-procedure
Gastrointestinal disorders Mechanical Ileus Obstruction	3.3% 1/30 • Number of events 1 • 30 days post-procedure
Gastrointestinal disorders Clostridium Infection	3.3% 1/30 • Number of events 1 • 30 days post-procedure

Other adverse events

Other adverse events
Measure	Levita Magnetic Surgical System n=30 participants at risk Levita Magnetic Surgical System
Gastrointestinal disorders Petechias Peritoneal	16.7% 5/30 • Number of events 5 • 30 days post-procedure
Surgical and medical procedures Wound Infection	3.3% 1/30 • Number of events 1 • 30 days post-procedure

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