Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TransLoc electrode | Experimental | Electrode placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransLoc electrode | Device | Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery. |
|
| 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. |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond Onders, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Events | Implantation through hospital discharge or Day 7, whichever comes first. |
|
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Serious device or procedure adverse device effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Ignagni | Synapse Biomedical | 440-774-2488 | 110 | aignagni@synapsebiomedical.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
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 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Postoperatively on Day 1 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of predicted tidal volume | Postoperatively Day 1 |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Postop Day 1 through hospital discharge or Day 7, whichever comes first |
|
|
|
| Primary | 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. | Four subjects were enrolled into each of the following surgical procedural groups: laparoscopic, open abdominal and open chest. | Posted | Count of Participants | Participants | Postop Day 1 through hospital discharge or 7 days, whichever comes first |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Postop Day 1 through hospital discharge or Day 7, whichever comes first |
|
|
|
| Secondary | Comparison of Percentage of Predicted Tidal Volumes Measured. | Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm. | 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. | Posted | Mean | Standard Deviation | percentage of predicted tidal volume | Postop Day 1 |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Postop Day 1 |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Postop Day 1 through hospital discharge or Day 7, whichever comes first |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided