ClinicalTrials.gg
RecruitingNCT07665320Updated Jun 29, 2026

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

An observational study in Deep Vein Thrombosis (DVT), sponsored by Tampere University. Recruiting at 2 sites in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Tampere University · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

  1. Collect IPG data for developing signal processing, data analysis and ML algorithms for DVT detection and assessment.
  2. Evaluate the performance of the developed methods to gold standard references including angiography, ultrasound imaging and venous occlusion plethysmography.
  3. Investigate whether multi-frequency IPG measurement improves the performance of DVT detection compared to single frequency measurement and determine the optimal measurement frequency.
  4. 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

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

02

Conditions studied

  • Deep Vein Thrombosis (DVT)

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Keywords

  • deep vein thrombosis
  • DVT
03

In context

Venous Thrombosis

785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.

This study's planned enrollment of 40 is below the median of 301 across 274 observational studies indexed under Venous Thrombosis.

Browse Venous Thrombosis studies →

Lead sponsor

Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Tampere

Eligibility criteria

Inclusion Criteria for Patients group:

  • Age: 18 or older;
  • DVT detected on other lower limb;
  • Suitable for CDT treatment;
  • Ability to give ;
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

    DVT detected on other lower limb, undergoing catheter-directed thrombolysis

    Device: Impedance plethysmography IPG · Device: Venous Occlusion Plethysmography VOP · Other: Breathing and leg movement exercise

  • Healthy volunteers

    Healthy volunteers

    Device: Impedance plethysmography IPG · Device: Venous Occlusion Plethysmography VOP · Other: Breathing and leg movement exercise

Interventions

  • DeviceImpedance plethysmography IPG

    IPG signal is measured with ThrombUS+ prototype device

    Also known as: IPG

  • DeviceVenous 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).

    Also known as: VOP

  • OtherBreathing 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.

    Also known as: Valsalva

06

What researchers measure

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)

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07665320
Lead sponsor
Tampere University
Responsible party
Antti Vehkaoja (Professor, Tampere University) — Principal investigator
First posted
Jun 24, 2026
Start date
Jul 17, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Vehkaoja
Contact
antti.vehkaoja@tuni.fi
+358407393181

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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