Varicose VeinsNCT02051439
The Party Balloon Assisted Valsalva in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
A study testing Valsava in people with Varicose Veins and Venous Insufficiency, run by Mahidol University.
Trial summary
This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins, Venous Insufficiency
- What is being tested?
- Valsava
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age within 18-80 years old
- Visible GSV varicose veins
- Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
- Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
- Consent to participate in the study.
Who cannot join
- - CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
- Failure to language communication
- Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
- Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
- Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)
About this study
Official title: A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.
Read the detailed description
In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.
- Conditions
- Varicose Veins, Venous Insufficiency
- Being tested
- Valsava
- Keywords
- Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava
- Medical subject headings
- Varicose Veins, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsavaProcedure or surgery
The patients were randomized to 2 groups. The first group performed conventional Valsava 3 times before balloon assisted Valsava 3 times. The second group performed balloon assisted Valsava 3 times before conventional Valsava 3 times for venous reflux examination by duplex scan.
| Study group | Role | What they receive |
|---|---|---|
| Valsava | Other | The patients were randomized to 2 groups. The first group performed conventional Valsava before balloon assisted Valsava. The second group performed balloon assisted Valsava before conventional Valsava for venous reflux examination by duplex scan. Receives: Procedure: Valsava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successfully identified reflux with different method of Valsava technic
Patients performed conventional Valsava for identify venous reflux on duplex scan for 3 times then they performed balloon assisted Valsava for identify venous reflux on duplex scan for 3 times. The Outcome is number of successfully identified reflux with different method of Valsava technic.
Measured: 20 minutes
Secondary outcomes (3)
The timing for the instruction of conventional Valsava and balloon assisted Valsava
The time for training patients to performed conventional Valsava and balloon assisted Valsava before duplex examination was compared
Measured: 20 minutes
The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava
The time of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava was compared
Measured: 20 minutes
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava was compared
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051439
- Sponsor's protocol ID
- SIRIRAJ11SU00030/028/11
- Status last verified
- Jan 2014
- First submitted
- 27 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
- ClinicalTrials.gov ID
- NCT02051439
- Acronym / sponsor ID
- SIRIRAJ11SU00030/028/11
- Conditions
- Varicose Veins, Venous Insufficiency
- Keywords
- Varicose Veins, Venous Insufficiency, Doppler, Duplex, Valsava
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Jan 2014 (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.
This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.
Detailed description
In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valsava | Other | Procedure: ValsavaThe patients were randomized to 2 groups. The first group performed conventional Valsava before balloon assisted Valsava. The second group performed balloon assisted Valsava before conventional Valsava for venous reflux examination by duplex scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age within 18-80 years old
- Visible GSV varicose veins
- Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
- Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
- Consent to participate in the study.
Key exclusion criteria (5 listed)
- - CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
- Failure to language communication
- Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
- Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
- Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)
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 |
|---|---|---|
| ValsavaThe patients were randomized to 2 groups. The first group performed conventional Valsava 3 times before balloon assisted Valsava 3 times. The second group performed balloon assisted Valsava 3 times before conventional Valsava 3 times for venous reflux examination by duplex scan. | Procedure or surgery | Valsava |
Primary outcome
Number of successfully identified reflux with different method of Valsava technic
Time frame: 20 minutes
Patients performed conventional Valsava for identify venous reflux on duplex scan for 3 times then they performed balloon assisted Valsava for identify venous reflux on duplex scan for 3 times. The Outcome is number of successfully identified reflux with different method of Valsava technic.
3 secondary outcomes
The timing for the instruction of conventional Valsava and balloon assisted Valsava
Time frame: 20 minutes
The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava
Time frame: 20 minutes
The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava
Time frame: 20 minutes
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 31 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Valsava in people with Varicose Veins and Venous Insufficiency, run by Mahidol University.
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 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 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of successfully identified reflux with different method of Valsava technic (time frame: 20 minutes). 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 31 Jan 2014.