Trial Outcomes & Findings for Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures (NCT NCT02410798)

Results Overview

All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Implantation through hospital discharge or Day 7, whichever comes first.

Results posted on

2021-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	TransLoc Electrode Electrode placement TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TransLoc Electrode n=12 Participants Electrode placement TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=12 Participants
Age, Categorical >=65 years	8 Participants n=12 Participants
Age, Continuous	67.6 years n=12 Participants
Sex: Female, Male Female	5 Participants n=12 Participants
Sex: Female, Male Male	7 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: Implantation through hospital discharge or Day 7, whichever comes first.

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Participant That Experience Adverse Procedure and/or Device Effects	0 Events

PRIMARY outcome

Timeframe: Postoperatively on Day 1

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm	12 Participants

PRIMARY outcome

Timeframe: Postoperatively Day 1

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants	137 Percentage of predicted tidal volume Standard Deviation 30

PRIMARY outcome

Timeframe: Postop Day 1 through hospital discharge or Day 7, whichever comes first

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.	12 Participants

PRIMARY outcome

Timeframe: Postop Day 1 through hospital discharge or 7 days, whichever comes first

Population: Four subjects were enrolled into each of the following surgical procedural groups: laparoscopic, open abdominal and open chest.

Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.	12 Participants

PRIMARY outcome

Timeframe: Postop Day 1 through hospital discharge or Day 7, whichever comes first

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode	12 Participants

SECONDARY outcome

Timeframe: Postop Day 1

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Comparison of Percentage of Predicted Tidal Volumes Measured.	107 percentage of predicted tidal volume Standard Deviation 35

SECONDARY outcome

Timeframe: Postop Day 1

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Number of participants in which stimulation successfully achieves acceptable tidal volumes of at least 6cc/kg of predicted body weight (PBW). This predicted tidal volume measurement is based on the NIH NHLBI ARDS Clinical Network (ARDSnet) MV protocol criteria for Acute Respiratory Lung Syndrome (ARDS) protection resulting from the ALVELOI study.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)	12 Participants

SECONDARY outcome

Timeframe: Postop Day 1 through hospital discharge or Day 7, whichever comes first

Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.

Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.	12 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Ignagni

Synapse Biomedical

Phone: 440-774-2488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place