Venous InsufficiencyNCT03652025
The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
A study testing embolotherapy of incompetent gonadal and iliac veins in people with Venous Insufficiency, run by Assiut University.
Trial summary
pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency . chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- embolotherapy of incompetent gonadal and iliac veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2018to 15 Jun 2019
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal women ovarian point tenderness post coital pain atypical lower limb varices
Who cannot join
- endometriosis diverticulitis fasciitis psychosexual dysfunction
About this study
pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .
chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.
Read the detailed description
this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.
follow up assessment by VAS score and duplex imaging.
- Conditions
- Venous Insufficiency
- Being tested
- embolotherapy of incompetent gonadal and iliac veins
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolotherapy of incompetent gonadal and iliac veinsProcedure or surgery
minimally invasive
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | perimenopausal women Receives: Procedure: embolotherapy of incompetent gonadal and iliac veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in pain score before and after therapy
validated analogue scoring of pain From 0 to 10 according to symptoms improvement
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Oct 2018 (estimated)
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Model description
- premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmadnaserhussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652025
- Sponsor's protocol ID
- AssiutU777
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities
- ClinicalTrials.gov ID
- NCT03652025
- Acronym / sponsor ID
- AssiutU777
- Conditions
- Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 29 Aug 2018 (actual)
- 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.
pelvic congestion is the most recognized consequence of pelvi-perineal venous insufficiency .
chronic pelvic pain prevalence is about 26.6 %in egypt. this research is going to evaluate the effectiveness of foam sclerotherapy and to conclude diagnostic and therapeutic algorithm for this problem.
Detailed description
this study includes clinical and imaging and interventional aspects. detailed history and comprehensive examination of the patient. duplex ultrasonography to detect pelvic varices and presence of reflux. renal and left iliac venogram is usually the first step in the evaluation of compressive syndrome. then cannulate the gonadal and internal iliac veins selectively. contrast medium injected , the incompetent gonadal veins are generally dilated and the contrast pools in the pelvis after injection. embolization by injecting afoam sclerosant as distally as possible to occlude the pelvic venous plexus using occlusion balloon proximal.
follow up assessment by VAS score and duplex imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- premenopausal women with dull aching pain with ovarian point tenderness and post coital pain.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: embolotherapy of incompetent gonadal and iliac veinsperimenopausal women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- premenopausal women ovarian point tenderness post coital pain atypical lower limb varices
Key exclusion criteria (1 listed)
- endometriosis diverticulitis fasciitis psychosexual dysfunction
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 |
|---|---|---|
| embolotherapy of incompetent gonadal and iliac veinsminimally invasive | Procedure or surgery | Study group |
Primary outcome
The difference in pain score before and after therapy
Time frame: one year
validated analogue scoring of pain From 0 to 10 according to symptoms improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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 embolotherapy of incompetent gonadal and iliac veins in people with Venous Insufficiency, run by Assiut 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 1 inclusion and 1 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 Aug 2018. 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?
Results are not available in the source record.
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?
The difference in pain score before and after therapy (time frame: one 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 29 Aug 2018.