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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06415058
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 and older
* Willing to adhere to the HemoIV intervention regimen
* Patient scheduled for a hospital procedure for medical condition requiring peripheral intravenous catheter placement, intravenous therapy, and blood draw
* Patients to receive intravenous therapy including: Normal Saline, Lactate Ringer, or 5% Dextrose in Water.
* Patient with peripheral intravenous catheter access vein size \> 2 mm in diameter or per investigator discretion able to accept an 18G Peripheral Intravenous Catheter.
* Patient must be able to have a peripheral IV catheter in one arm and can have standard venipuncture blood draws from contralateral arm.
* Patient must be able to have an 18G Peripheral Intravenous Catheter inserted for use with the study device up to 1.88" in length.
Exclusion Criteria:
* Do not speak/understand English
* Patients who have a prior history of mastectomy
* Concurrent participation/treatment with another investigational drug or other intervention study.
* Patient with signs and symptoms of thrombophlebitis at the IV site at the time of study enrollment
* Patients receiving chemotherapy, or who have leukemia for example who have fragile formed cellular element
* Patients which are hemodynamically unstable
* Patients requiring blood transfusion via the 18G peripheral IV catheter used with HemoIV
* Patients who are unable to have a peripheral IV catheter on one upper extremity while having the other upper extremity available for blood tests (e.g. subjects must have two arms, not have an AV graft or fistula anticipating dialysis in the near future, etc.)
* Subjects who are not able to have an IV infusion rate adjusted in the HemoIV to between 10-250 mL/hr during blood draws via HemoIV
* Patient with morbid obesity, (BMI \> 40)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06415058
Study Brief:
Protocol Section:
NCT06415058