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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03531268
Eligibility Criteria:
Inclusion Criteria:
1. Adults 18 years of age or older at screening.
2. Adults with qualifying insurance coverage.
3. Subjects scheduled to undergo elective surgery with an expected hospitalization 24 hrs =/- 4 hrs after surgery.
4. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
5. One or more of the following:
* Subjects prescribed 4 or more medications at time of surgery.
* Any subject prescribed any one of the following medication categories: opioid, benzodiazepine, antidepressant, antipsychotic, stimulant, mood stabilizer, NSAIDs, anti-epileptic drugs.
* Any subject prescribed any one of the following medication categories: antiplatelet therapy, anticoagulant drugs.
6. Able to provide informed consent, adhere to the study protocol, and complete all study assessments.
Exclusion Criteria:
1. Subjects who do not have insurance coverage for PGx testing.
2. Subjects who are expected to have surgery prior to the ability to obtain the results of the pharmacogenomic testing (generally it takes 4 days to obtain the results of testing).
3. Subjects who are not being prescribed 4 or more medications, or who are not receiving any of the medication categories noted in the inclusion criteria.
4. Planned multiple surgical procedures within the 30-day study follow up period.
5. Clinically significant medical or psychiatric disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease that would cause the subject to be unable to comply with the study requirements.
6. Administration of an investigational drug within 30 days prior to providing PGx testing, or planned administration of an investigational product during the subject's participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03531268
Study Brief:
Protocol Section:
NCT03531268