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NCT Number: NCT07665320

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University, Tampere, Finland

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About this study

This study aims to collect IPG data set from healthy volunteers and DVT patients using ThrombUS+ prototype device developed during the project and commercial IPG device as a reference. The data will be used to develop ThrombUS+ IPG device, its signal processing and analysis algorithms and to train ML models.

Objectives of the study are to

  • Collect IPG data for developing signal processing, data analysis and ML algorithms for DVT detection and assessment.
  • Evaluate the performance of the developed methods to gold standard references including angiography, ultrasound imaging and venous occlusion plethysmography.
  • Investigate whether multi-frequency IPG measurement improves the performance of DVT detection compared to single frequency measurement and determine the optimal measurement frequency.
  • Investigate and compare different interventions to cause changes in venous blood volume for DVT detection, such as venous occlusion by thigh cuff, active respiration and muscle activation.

Secondary objectives are

  • To investigate methods for simulating DVT and to compare the performance of these methods for DVT simulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patients group:

  • Age: 18 or older;
  • DVT detected on other lower limb;
  • Suitable for CDT treatment;
  • Ability to give informed consent;
  • Volunteering for the study.

Exclusion criteria

for Patients group:

  • Age under 18 years;
  • Inability to give informed consent;
  • Denial;
  • Too injured skin in the measurement area

Inclusion criteria

for Healthy volunteers group:

  • Age: 18 or older;
  • Ability to give informed consent;
  • Volunteering for the study

Exclusion criteria

for Healthy volunteers group:

  • Diagnosed DVT in lower limbs;
  • Age under 18 years;
  • Inability to give informed consent;
  • Denial;
  • Too injured skin in the measurement area.

Treatment and study plan

Impedance plethysmography IPG

Device

IPG signal is measured with ThrombUS+ prototype device

Other names: IPG

Venous Occlusion Plethysmography VOP

Device

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 names: VOP

Breathing and leg movement exercise

Other

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.

Other names: Valsalva

Primary outcomes

  1. Impedance plethysmography (IPG) data during CDT treatment

    Time frame: From enrollment to the end of the CDT treatment (up to 2 days)

  2. Impedance plethysmography (IPG) data from healthy volunteers

    Time frame: From enrollment to the end of measurements (up to 2 hours)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Tampere University Hospital

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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