Status:

RECRUITING

CoMind Early Feasibility Study

Lead Sponsor:

CoMind Technologies Limited

Collaborating Sponsors:

Lindus Health

Conditions:

Intracranial Pressure

Intracranial Pressure Changes

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) t...

Detailed Description

A prospective, observational study, determined as non-significant risk by the Central IRB, to assess and improve performance of a non-invasive ICP estimation system. The development of non-invasive sy...

Eligibility Criteria

Inclusion Criteria:

  1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
  2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
  3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
  4. Receiving continuous invasive ABP monitoring as part of standard care.

Exclusion Criteria:

  1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.
  2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
  3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
  4. If patient is enrolled in an intervention/study that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.
  5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.

Key Trial Info

Start Date :

November 27 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

581 Patients enrolled

Trial Details

Trial ID

NCT06368648

Start Date

November 27 2024

End Date

November 1 2026

Last Update

February 13 2026

Active Locations (14)

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Page 1 of 4 (14 locations)

1

UC Davis Medical Center

Sacramento, California, United States, 95817

2

Christiana Care

Wilmington, Delaware, United States, 19899

3

Medstar Health

Washington D.C., District of Columbia, United States, 20010

4

Jackson Memorial Hospital

Miami, Florida, United States, 33136