Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures

Study Overview
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Brief Summary
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Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).

Detailed Description
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This is a prospective, open-label, single-center study to examine the feasibility of the TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes) and will be followed until electrode removal up to seven days post-procedure. Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures.

Official Title
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Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures

Conditions
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Diaphragm Pacing

Intervention / Treatment
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* Device: TransLoc electrode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing a surgical procedure with expected admission to the hospital. Patient is undergoing a laparoscopic, open abdominal, or open chest surgical procedure that allows access to the diaphragm. Negative pregnancy test if the patient is a female of child-bearing potential. Patient is at least 18 years of age. Informed consent has been obtained from the patient or designated representative. Exclusion Criteria: Patient has an implanted cardiac defibrillator. Patient is pregnant or breastfeeding. The patient is involved in another clinical study that could influence the safety or outcome measures of this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TransLoc electrode<br>Electrode placement | Device: TransLoc electrode<br>* Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant That Experience Adverse Procedure and/or Device Effects | All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal. | Implantation through hospital discharge or Day 7, whichever comes first. | 
| Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm | 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. | Postoperatively on Day 1 | 
| Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants | Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant. | Postoperatively Day 1 | 
| Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured. | Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants. | Postop Day 1 through hospital discharge or Day 7, whichever comes first | 
| Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed. | 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. | Postop Day 1 through hospital discharge or 7 days, whichever comes first | 
| Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode | 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. | Postop Day 1 through hospital discharge or Day 7, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Percentage of Predicted Tidal Volumes Measured. | Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm. | Postop Day 1 | 
| Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW) | 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. | Postop Day 1 | 
| Number of Participants With Successful Measurement and Characterization of Diaphragm Activity. | Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant. | Postop Day 1 through hospital discharge or Day 7, whichever comes first |