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

NCT02410798 | Completed Results

• 1 other identifier: CLIN 20-1000-0006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Diaphragm Pacing

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Comparison of Percentage of Predicted Tidal Volumes Measured.

  Postop Day 1

• Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)

  Postop Day 1

• Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.

  Postop Day 1 through hospital discharge or Day 7, whichever comes first

Study Arms (1)

TransLoc electrode

EXPERIMENTAL

Electrode placement

Device: TransLoc electrode

Interventions

TransLoc electrode DEVICE

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

TransLoc electrode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synapse Biomedical: lead

Study Sites (1)

University Hospital

Cleveland, Ohio, 44106, United States

Location

Results Point of Contact

• Title: Anthony Ignagni
• Organization: Synapse Biomedical

aignagni@synapsebiomedical.com

440-774-2488

Study Officials

• Raymond Onders, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 8, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Locations

US (1)