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NCT Number: NCT02410798

Clinical Study to Investigate Safety and Performance of TransLoc Electrodes 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).

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Key information

Conditions

Diaphragm Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TransLoc electrode

Device

Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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 outcomes

  1. Comparison of Percentage of Predicted Tidal Volumes Measured.

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Synapse Biomedical

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2015
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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