Chronic Venous InsufficiencyNCT01000909
Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins
An observational study of Chronic Venous Insufficiency, run by University of Zurich at 1 site in Switzerland.
Trial summary
Part I: Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons Part II: Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Ultrasound (venous pressure measurement)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic venous disease with complete incompetence of the great saphenous vein
Who may be able to join
- Part I:
- Healthy persons without clinical signs of venous disease, informed consent
- Part II:
- Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV)
- Informed consent
Who cannot join
- Part I:
- Clinical signs of venous disease, former deep vein thrombosis (DVT)
- Part II:
- Former deep vein thrombosis, former vein surgery
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
About this study
Part I:
Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons
Part II:
Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Ultrasound (venous pressure measurement)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (venous pressure measurement)Procedure or surgery
increased venous pressure is predictive for chronic venous insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000909
- Sponsor's protocol ID
- CT-02-2009-USZ
- Status last verified
- Jun 2010
- First submitted
- 22 Oct 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins
- ClinicalTrials.gov ID
- NCT01000909
- Acronym / sponsor ID
- CT-02-2009-USZ
- Conditions
- Chronic Venous Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2009
- Study completion
- Jul 2010
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part I:
Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons
Part II:
Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic venous disease with complete incompetence of the great saphenous vein
Key inclusion criteria (5 listed)
- Healthy persons without clinical signs of venous disease, informed consent
- Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV)
- Informed consent
Key exclusion criteria (4 listed)
- Clinical signs of venous disease, former deep vein thrombosis (DVT)
- Former deep vein thrombosis, former vein surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound (venous pressure measurement)increased venous pressure is predictive for chronic venous insufficiency | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins contact
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.