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RECRUITING
NCT07665320

Impedance Plethysmography Based Deep Vein Thrombosis Monitoring During Catheter-directed Thrombolysis

Sponsor: Tampere University

View on ClinicalTrials.gov

Summary

The purpose of this study is to collect data on blood circulation using a multi-frequency impedance plethysmography device developed in the ThrombUS+ project. Impedance plethysmography (IPG) is a non-invasive method that measures changes in blood volume using electrodes placed on the skin. The collected data will be used for device development, the improvement of diagnostic data analysis methods, and AI training. A total of 40 participants will be recruited for this study, with 20 healthy volunteers in Tampere University and 20 patients undergoing thrombolytic therapy for DVT at Tampere University Hospital.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-07-17

Completion Date

2027-12

Last Updated

2026-06-29

Healthy Volunteers

Yes

Interventions

DEVICE

Impedance plethysmography IPG

IPG signal is measured with ThrombUS+ prototype device

DEVICE

Venous Occlusion Plethysmography VOP

In VOP measurement, a temporal blood restriction is caused by an occlusive cuff blocking venous outflow but allowing arterial inflow. The cuff intervention causes a change in venous blood volume, and it can be measured by electrical impedance plethysmography (IPG).

OTHER

Breathing and leg movement exercise

The first exercise is the Valsalva maneuver, where the subject first inhales and then pushes out the breath while the larynx is closed. In the second exercise, the subject inhales for approximately 10 seconds, holds the breath for approximately 5 seconds, and then breathes out. Finally, the subject moves the ankles to contract calf muscles, and further to cause changes in venous blood volume. The IPG signal is measured on both calves by ThrombUS+ prototype device during these exercises.

Locations (2)

Tampere University Hospital

Tampere, Finland

Tampere University

Tampere, Finland