Use of Electrical Bioimpedance in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients (Bioimpedance)

ConditionsMyelodysplastic Syndromes Acute Myeloid Leukemia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Utah

About this trial

The goal of this project is to test non-invasive, painless skin electrical bioimpedance (BioZ) measurements as an adjunctive biomarker to standard bone marrow biopsies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Suspected or confirmed diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and undergoing a bone marrow biopsy.

Age 18 or older.

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Disqualifiers

Study prospect that has an electronic implant (cardiac, neurological, sensory, prosthetic implants with an electronic component. Also monitoring and drug delivery systems.)

Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.

Pregnant women

Inability to understand and/or speak the English or Spanish language.

Trial population

Patients with suspected or confirmed diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Bioimpedance (BioZ)
Diagnostic test
The BioZ device uses a low-intensity electrical current that is applied from inside of the BioZ device that has small electrodes at the tip. To interrogate these electrical properties, the electrodes (tip of the device) will be placed on the skin in the area of the hip. Once this occurs, the electrodes will be activated and the low-intensity current will be applied. As the current moves through the skin the device has a probe to detect changes in current that may be associated with cancer. Data from the probe is related to a secure phone that has an app to collect information.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Patients with Suspected or AML or MDS1 intervention

Trial outcomes

Primary outcomes

Correlate BioZ findings with Pathologic Results

The primary outcome measure of this study is to correlate BioZ findings with pathologic results from bone marrow biopsies with AML or MDS.

Time frame

up to one day

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: