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

• Sponsor: Synapse Biomedical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02410798
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Diaphragm Pacing	Device: TransLoc electrode	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TransLoc electrode Electrode placement	Device: TransLoc electrode; Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.

Outcome Measures

Primary Outcome Measures

1. Number of Participant That Experience Adverse Procedure and/or Device Effects [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.

2. Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm [Postoperatively on Day 1]

   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.

3. Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants [Postoperatively Day 1]

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

4. Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured. [Postop Day 1 through hospital discharge or Day 7, whichever comes first]

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

5. Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed. [Postop Day 1 through hospital discharge or 7 days, whichever comes first]

   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.

6. Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode [Postop Day 1 through hospital discharge or Day 7, whichever comes first]

   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.

Secondary Outcome Measures

1. Comparison of Percentage of Predicted Tidal Volumes Measured. [Postop Day 1]

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

2. Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW) [Postop Day 1]

   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.

3. Number of Participants With Successful Measurement and Characterization of Diaphragm Activity. [Postop Day 1 through hospital discharge or Day 7, whichever comes first]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Synapse Biomedical

Investigators

• Principal Investigator: Raymond Onders, MD, University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synapse Biomedical
• ClinicalTrials.gov Identifier: NCT02410798
• Other Study ID Numbers: CLIN 20-1000-0006
• First Posted: Apr 8, 2015
• Last Update Posted: Jul 20, 2021
• Last Verified: Jun 1, 2021

Study Results

Participant Flow

Arm/Group Title	TransLoc Electrode
Arm/Group Description	Electrode placement TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TransLoc Electrode
Arm/Group Description	Electrode placement TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 33.3%
>=65 years	8 66.7%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67.6
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participant That Experience Adverse Procedure and/or Device Effects
Description	All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Time Frame	Implantation through hospital discharge or Day 7, whichever comes first.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Number [Events]	0

2. Primary Outcome

Title	Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Description	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.
Time Frame	Postoperatively on Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

3. Primary Outcome

Title	Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Description	Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Time Frame	Postoperatively Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Mean (Standard Deviation) [Percentage of predicted tidal volume]	137 (30)

4. Primary Outcome

Title	Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Description	Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
Time Frame	Postop Day 1 through hospital discharge or Day 7, whichever comes first

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

5. Primary Outcome

Title	Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Description	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.
Time Frame	Postop Day 1 through hospital discharge or 7 days, whichever comes first

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

6. Primary Outcome

Title	Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Description	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.
Time Frame	Postop Day 1 through hospital discharge or Day 7, whichever comes first

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

7. Secondary Outcome

Title	Comparison of Percentage of Predicted Tidal Volumes Measured.
Description	Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.
Time Frame	Postop Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in each hemi-diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Mean (Standard Deviation) [percentage of predicted tidal volume]	107 (35)

8. Secondary Outcome

Title	Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Description	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.
Time Frame	Postop Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

9. Secondary Outcome

Title	Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Description	Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.
Time Frame	Postop Day 1 through hospital discharge or Day 7, whichever comes first

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/Group Description	Patients will have 2 TransLoc electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Measure Participants	12
Count of Participants [Participants]	12 100%

Adverse Events

Time Frame	All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Adverse Event Reporting Description	Serious device or procedure adverse device effects.
Arm/Group Title	Treatment
Arm/Group Description	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 Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.