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Recruiting
NCT07394140
NMT EasyFit Sensor and Cable
Conditions: Neuromuscular Blockade Monitoring, NMT
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: GE Healthcare
Location: Loma Linda University Health Loma Linda California
Summary
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
Inclusion Criteria:
1. Study subject (male or female) is age 18 years or older (≥18 years).
2. Study subject must have the ability to understand and provide written informed consent.
3. Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication.
4. Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand/forearm.
Exclusion Criteria:
1. Are known to be pregnant.
2. Are breastfeeding.
3. Suffering from an infection(s) that requires isolation.
4. 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.
5. Subjects requiring rapid sequence induction
6. Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study.
7. Direct employees or contractors of GE HealthCare, or any company that makes NMT monitoring devices (sensors, cables, modules).
8. NMT ElectroSensor placed on the foot/ankle
Source: ClinicalTrials.gov (NCT07394140). StuddyBuddy aggregates publicly available trial information.