Clinical trial NCT02410798: Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm Pacing
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participant That Experience Adverse Procedure and/or Device Effects
timeFrame: Implantation through hospital discharge or Day 7, whichever comes first.
measure: Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
timeFrame: Postoperatively on Day 1
measure: Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
timeFrame: Postoperatively Day 1
measure: Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
timeFrame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
measure: Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
timeFrame: Postop Day 1 through hospital discharge or 7 days, whichever comes first
measure: Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
timeFrame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Secondary outcomes:
measure: Comparison of Percentage of Predicted Tidal Volumes Measured.
timeFrame: Postop Day 1
measure: Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
timeFrame: Postop Day 1
measure: Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
timeFrame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University Hospitals
name: Raymond Onders, MD
role: PRINCIPAL_INVESTIGATOR
References: