NMT EasyFit Sensor and Cable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
The purpose of this clinical study is to collect and assess feedback from clinical users regarding the functionality and device use and collection of raw parameter date from the NMT Sensor and NMT Cable.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study subject (male or female) is age 18 years or older (≥18 years).
Study subject must have the ability to understand and provide written informed consent.
Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication.
Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand/forearm.
Disqualifiers
Are known to be pregnant.
Are breastfeeding.
Suffering from an infection(s) that requires isolation.
Deformity, scar tissue, tattoos, or other characteristics at the sensor application area that could interfere (e.g., nerve damage) with the completion of the study procedure or identify a study subject.
Trial design
Design model
Single group
Treatments tested in this trial
Collection of NMT Technology
DeviceCollection and assessment of non-invasive electrical stimuli from the NMT measurement placed on the patient's hand and forearm to measure the level of neuromuscular blocking agents during standard of care surgical procedures.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: All SubjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Collection of End User Feedback Surveys
Collection of end user feedback surveys on the functionality and clinical use of the NMT Sensor and Cable during standard of care surgical procedure (minimum of 1 hour and maximum of 24 hours).
Time frame
Up to 24 hoursSecondary outcomes
1
Collection of raw parameter data from NMT Sensor and Cable
Collection of raw parameter data from NMT Sensor and Cable to evaluate the reliability of the measurements to NMBA concordance rate.
Time frame
Up to 24 hours2
Incidence of Safety Events
Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
Time frame
4 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GE Healthcare
Lead sponsor
Loma Linda University
Collaborator
Source ClinicalTrials.gov