CompletedNot Applicable

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

United States12 participantsStarted 2015-05

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Postoperatively on Day 1

Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants

Timeframe: Postoperatively Day 1

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

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

Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode

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

Trial details

NCT IDNCT02410798

SponsorSynapse Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2020-08-12

View on ClinicalTrials.gov More Diaphragm Pacing trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Postoperatively on Day 1

Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants

Timeframe: Postoperatively Day 1

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

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

Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode

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