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Clinical Trial Summary

Participants will be undergoing a scheduled vascular access intervention. On the procedure day, participants will be asked to wear the SmartPatch over top of their AV access before, after, and potentially during (PI discretion) their scheduled procedure. The SmartPatch readings will be compared with measurements collected during the scheduled vascular access intervention (e.g., degree of patency pre- and post-procedure). Additionally, blood flow data (via duplex ultrasound, transonic, EKO stethoscope and/or flow probes) and basic vitals may also be collected during this time. Participants may also undergo a blood draw during the procedure to compare values of hemoglobin, hematocrit, potassium, etc. with SmartPatch readings.


Clinical Trial Description

The Physician principal investigator will identify patients under his care that meet the inclusion criteria as potential participants for the study described below. The physician PI/ or his delegated clinical staff will offer these individuals to participate in this study. If these participants meet all the eligibility criteria and are willing to participate, participants will complete the informed consent process. Baseline Testing includes: - Basic physical exam (i.e., vital signs, weight) - Vascular access history These subjects will then be considered enrolled upon completion of the screening assessments. Participants will be undergoing a scheduled vascular access intervention. On the procedure day, participants will be asked to wear the SmartPatch over top of their AV access before, after, and potentially during (PI discretion) their scheduled procedure. The SmartPatch readings will be compared with measurements collected during the scheduled vascular access intervention (e.g., degree of patency pre- and post-procedure). Additionally, blood flow data (via duplex ultrasound, transonic, EKO stethoscope and/or flow probes) and basic vitals may also be collected during this time. Participants may also undergo a blood draw during the procedure to compare values of hemoglobin, hematocrit, potassium, etc. with SmartPatch readings. Participants will be exited from the study following their post-procedure assessments and SmartPatch readings. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05178940
Study type Observational
Source Alio Medical
Contact
Status Active, not recruiting
Phase
Start date October 11, 2021
Completion date December 2022

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