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Tacrolimus Microsampling

NCT04810143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-12-20

No results posted yet for this study

Summary

This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.

Conditions

  • Validate Volumetric Absorptive Microsampling (VAMS) Assay

Interventions

DEVICE

Mitra Microsampler

an FDA Class I medical device for direct specimen collection of blood or other biological fluids

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Thomas C Ryan · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2022-01-03
Completion
2022-07-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810143 on ClinicalTrials.gov