NMT EasyFit Sensor and Cable

Evaluate Functionality and Use of the NMT EasyFit Sensor and NMT EasyFit Cable

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade Monitoring; NMT
• Intervention / Treatment: Device: Collection of NMT Technology

Detailed Description

The NMT Sensor provides quantitative, automated measurements of neuromuscular block by delivering non-invasive electrical stimuli to the ulnar nerve and recording electromyography (EMG) responses from the adductor pollicis muscle. Surface hydrogel electrodes with adhesive foam ensure secure placement for continuous monitoring. The single-use sensor connects to a reusable NMT Cable and is designed for use with GE HealthCare NMT measurement devices (NMT Module and bedside monitors).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa McCabe, MD; Phone Number: 909-558-4475; Email: mmccabe@llu.edu
• Study Contact Backup: Name: Morgan Blazy; Phone Number: 909-558-4256; Email: Mblazy@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health
      • Contact: Blazy Morgan; Phone Number: 909-558-4256; Email: Mblazy@llu.edu
      • Principal Investigator: Melissa McCabe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Subjects; Placement of NMT Sensor on Hand and Forearm	Device: Collection of NMT Technology; Collection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 hours
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.	4 months.

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SA-000175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No