Postphlebitic SyndromePhase 3NCT00182208
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
A Phase 3 study testing Veno-device (Venowave) in people with Postphlebitic Syndrome, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postphlebitic Syndrome
- What is being tested?
- Veno-device (Venowave)
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- May 2004to Dec 2005
- Phase
- Phase 3
- 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
Who may be able to join
- Past History of objectively documented deep vein thrombosis
- Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
- Over 18 years of age (and of either gender).
- Villalta score of greater than 14(i.e.severe post phlebitic syndrome)
Who cannot join
- Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
- Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
- Active venous ulceration
- Baseline leg circumference greater than 50 cm (cuff will not fit subject)
- Symptomatic peripheral arterial disease Peripheral neuropathy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Henderson Research Centre
Hamilton, Ontario, L8V 1C3
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.
Read the detailed description
Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}
- Conditions
- Postphlebitic Syndrome
- Being tested
- Veno-device (Venowave)
- Keywords
- PTS, Post phlebitic Syndrome, Activities of Daily Living, Quality of Life
- Medical subject headings
- Postphlebitic Syndrome, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veno-device (Venowave)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success measured with the Global Rating Instrument
Secondary outcomes (3)
PTS-CCS questionnaire
Villalta Scale
Veines Quality of Life Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postphlebitic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Investigators
- Martin O'Donnell, MB MRCPI, Principal investigator, Hamilton Health Sciences CorporationSusan R Kahn, MD FRCPC, Principal investigator, Department of Medicine McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182208
- Sponsor's protocol ID
- CTMG-2005-VENOPTS
- Other IDs
- Health Canada No.:64844
- Status last verified
- Jul 2008
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00182208
- Acronym / sponsor ID
- CTMG-2005-VENOPTS
- Conditions
- Postphlebitic Syndrome
- Keywords
- PTS, Post phlebitic Syndrome, Activities of Daily Living, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- May 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.
Detailed description
Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Past History of objectively documented deep vein thrombosis
- Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
- Over 18 years of age (and of either gender).
- Villalta score of greater than 14(i.e.severe post phlebitic syndrome)
Key exclusion criteria (5 listed)
- Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
- Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
- Active venous ulceration
- Baseline leg circumference greater than 50 cm (cuff will not fit subject)
- Symptomatic peripheral arterial disease Peripheral neuropathy
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 |
|---|---|---|
| Veno-device (Venowave) | Device | – |
Primary outcome
Clinical Success measured with the Global Rating Instrument
3 secondary outcomes
PTS-CCS questionnaire
Villalta Scale
Veines Quality of Life Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2008.
Related trials for Postphlebitic Syndrome
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DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
Not yet recruitingObservational study
Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study
Iliofemoral Vein Stenosis, Iliofemoral Vein Occlusion
Recruiting
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Vascular, DVT - Deep Vein Thrombosis
RecruitingPhase 3
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
Venous Thromboembolism
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.
Martin O'Donnell, MB MRCPI principal investigator
Hamilton Health Sciences Corporation
Susan R Kahn, MD FRCPC principal investigator
Department of Medicine McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Veno-device (Venowave) in people with Postphlebitic Syndrome, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success measured with the Global Rating Instrument. It is what the study was designed to measure, not a finding.
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 22 Jul 2008.