- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02410798
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
June 29, 2021 updated by: Synapse Biomedical
Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TransLoc electrode
Electrode placement
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Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participant That Experience Adverse Procedure and/or Device Effects
Time Frame: Implantation through hospital discharge or Day 7, whichever comes first.
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All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
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Implantation through hospital discharge or Day 7, whichever comes first.
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Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Time Frame: Postoperatively on Day 1
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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.
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Postoperatively on Day 1
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Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Time Frame: Postoperatively Day 1
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Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
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Postoperatively Day 1
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Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Time Frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
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Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
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Postop Day 1 through hospital discharge or Day 7, whichever comes first
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Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Time Frame: Postop Day 1 through hospital discharge or 7 days, whichever comes first
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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.
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Postop Day 1 through hospital discharge or 7 days, whichever comes first
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Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Time Frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
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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.
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Postop Day 1 through hospital discharge or Day 7, whichever comes first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Percentage of Predicted Tidal Volumes Measured.
Time Frame: Postop Day 1
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Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.
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Postop Day 1
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Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Time Frame: Postop Day 1
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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.
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Postop Day 1
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Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Time Frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
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Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.
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Postop Day 1 through hospital discharge or Day 7, whichever comes first
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raymond Onders, MD, University Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 2, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 8, 2015
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CLIN 20-1000-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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