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:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT03625232
Eligibility Criteria:
Inclusion Criteria:
* The subject is at least 18 years of age at screening, but has not had his/her 91st birthday.
* The subject is required to have epidural procedure implemented as part of their standard medical treatment according to Principal Investigator assessment.
* The subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment into this study.
* The subject is willing to participate in this study for at least 30 days after the epidural procedure implementation.
* The subject is willing to participate in this study for at least 3 days after the procedure.
Exclusion Criteria:
* Contraindications for epidural procedure / anesthesia (circumstances where the risks associated with epidural procedures are higher than usual. These circumstances are, but not limited to, anatomical abnormalities, such as spina bifida or scoliosis, infection at or near the site of insertion, allergy to the anesthetic or intended drug, uncorrected hypovolemia, increased intracranial pressure etc.).
* Patients presenting for emergency C-section or other emergencies.
* Exclusive use of other treatments such as intravenous analgesia with opioids.
* Prior back surgery in lumbar area that would prevent epidural access.
* Preexisting neurological deficit that would interfere with dermatome identification.
* The subject observed seizure within 7 days prior to study enrollment.
* Presumed and/or confirmed septic embolus.
* The subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm2.
* The subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
* Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
* The subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03625232
Study Brief:
Protocol Section:
NCT03625232