Primary Chronic Venous InsufficiencyNCT00931424
The Clinical Trial for Primary Chronic Venous Insufficiency
A study testing valve reconstruction in people with Primary Chronic Venous Insufficiency, run by Sun Yat-sen University at 1 site in China.
Trial summary
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Primary Chronic Venous Insufficiency
- What is being tested?
- valve reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Dec 2015
- Phase
- Interventional
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography
Who cannot join
- age over 70 years old
- pregnancy
- patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Shen-ming Wang, Doctor, +86 020 87755766-8198, shenmingwang@sohu.com
Shen-ming Wang, professor
About this study
Official title: The Clinical Research of Surgery on Primary Chronic Venous Insufficiency
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.
- Conditions
- Primary Chronic Venous Insufficiency
- Being tested
- valve reconstruction
- Keywords
- Primary Chronic Venous Insufficiency, surgery, reconstruction, valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valve reconstructionProcedure or surgery
reconstruct valve at the same time of superficial vein surgery
| Study group | Role | What they receive |
|---|---|---|
| reconstruction | Experimental | patients in this group will have both valve reconstruction and superficial vein surgery Receives: Procedure: valve reconstruction |
| unreconstruction | No intervention | patients in this group will only have superficial vein surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical-etiology-anatomic-pathophysiologic classification system
Measured: 3 month, 1 year, 3 year, 5 year, 7 year
Secondary outcomes (2)
phlebography
Measured: 3 month, 1 year, 3 year, 5 year, 7 year
color doppler
Measured: 3 month, 1 year, 3 year, 5 year, 7 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Shen-ming Wang, doctor, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931424
- Sponsor's protocol ID
- 2008001
- Status last verified
- May 2009
- First submitted
- 30 Jun 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Surgery on Primary Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT00931424
- Acronym / sponsor ID
- 2008001
- Conditions
- Primary Chronic Venous Insufficiency
- Keywords
- Primary Chronic Venous Insufficiency, surgery, reconstruction, valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2015 (estimated)
- First posted
- 2 Jul 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.
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reconstruction | Experimental | Procedure: valve reconstructionpatients in this group will have both valve reconstruction and superficial vein surgery |
| unreconstruction | No intervention | –patients in this group will only have superficial vein surgery |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography
Key exclusion criteria (3 listed)
- age over 70 years old
- pregnancy
- patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy
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 |
|---|---|---|
| valve reconstructionreconstruct valve at the same time of superficial vein surgery | Procedure or surgery | reconstruction |
Primary outcome
clinical-etiology-anatomic-pathophysiologic classification system
Time frame: 3 month, 1 year, 3 year, 5 year, 7 year
2 secondary outcomes
phlebography
Time frame: 3 month, 1 year, 3 year, 5 year, 7 year
color doppler
Time frame: 3 month, 1 year, 3 year, 5 year, 7 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
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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.
Shen-ming Wang, doctor study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valve reconstruction in people with Primary Chronic Venous Insufficiency, run by Sun Yat-sen University at 1 site in China.
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 1 inclusion and 3 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 2 Jul 2009. 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 China. 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 Shen-ming Wang, Professor (+86 020 87755766-8198, shenmingwang@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical-etiology-anatomic-pathophysiologic classification system (time frame: 3 month, 1 year, 3 year, 5 year, 7 year). 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 2 Jul 2009.