Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT05385718
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide legal informed consent and 18 years of age or older
* Resident of the contiguous United States and located within proximity of a designated research MRI facility
* Ability to travel to designated research MRI facilities
Exclusion Criteria:
* Unable to receive an MRI due to existing implanted medical devices that may be disrupted by magnetic field or metal components/fragments that may migrate due to magnetic fields (pacemaker or defibrillator, stimulators, or stimulator wires (pacing leads), non-removeable metal dentures/braces/wires, surgical clips, (drug) pumps. Note metallic dental crowns or fillings are permitted.
* Those with orbital (eye socket) trauma caused by a metallic object
* Those with metallic fragments within the eye (foundry workers)
* Those with implanted cardiac pacemakers, implantable cardioverter defibrillators (ICDs), or diaphragmatic pacemakers, cardiac resynchronization therapy devices, implantable cardiovascular monitors, implantable loop recorders, neurostimulators
* Those with intra-cranial vascular clips (aneurysm), or prosthetic heart valve
* Those with shrapnel form a prior accident
* Those with a LINX Reflux Management System to control gastro esophageal reflux disease (GERD)
* Those with non-removable insulin pumps or other drug pumps
* Those with cochlear implants
* Those with breast (inflatable breast tissue implants) or other tissue expanders (cosmetic or other implant)
* Those with tubal ligation clips or non-removable intrauterine device (IUD)
* Those with Sensimed Triggerfish ocular monitoring systems (glaucoma)
* Those receiving ambulatory care
* Employee of Ezra Health of California, P.C., Ezra AI Incorporated or Ezra AI Canada Incorporated
* Mental health disability, cognitive disability, neurological or other existing condition that may impact ability to provide informed consent
* Those that recently experienced a stroke that may impair judgement
* Those that have some difficulty or higher, remembering, concentrating, communicating, or being understood (sponsor reviewed)
* Individuals who otherwise may require a legally authorized individual (LAR) to provide consent on their behalf
* Those who do not have access to the internet through a mobile device or computer
* Those who are pregnant at the time of informed consent or prior to a scheduled MRI appointment
* Those who are incarcerated or on probation
* Those who may not have reading proficiency of study supported document languages (questionnaires, consent forms, or third-party oral translation services)
* Those who cannot read due to visual impairment and cannot provide an impartial witness to support informed consent or study survey questionnaires
* Those with a hearing impairment and cannot provide an impartial witness to support informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05385718
Study Brief:
Protocol Section:
NCT05385718