Venous MalformationNCT05586919
Treatment of Venous Malformation
A study testing Direct Puncture Repair / Ethanol and Direct Puncture Repair / Polidocanol in people with Venous Malformation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. Read more about this study
- Who is it for?
- Ages 18 months to 36 years
- Conditions the study is for
- Venous Malformation
- What is being tested?
- Direct Puncture Repair / Ethanol and Direct Puncture Repair / Polidocanol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Mar 2021
- 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 months to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with venous malformation of both genders and age above one year.
Who cannot join
- Age below one year.
- Patients had any other vascular malformations.
- Indication for contrast material or Alcohol and polidocanol injection.
- Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
- Pulmonary embolism.
- Acute Ischemia, and acute DVT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.
- Conditions
- Venous Malformation
- Being tested
- Direct Puncture Repair / Ethanol, Direct Puncture Repair / Polidocanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Puncture Repair / EthanolProcedure or surgery
Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair
Direct Puncture Repair / PolidocanolProcedure or surgery
Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair
| Study group | Role | What they receive |
|---|---|---|
| Direct Puncture Repair / Ethanol | Active comparator | Not described Receives: Procedure: Direct Puncture Repair / Ethanol |
| Direct Puncture Repair / Polidocanol | Active comparator | Not described Receives: Procedure: Direct Puncture Repair / Polidocanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heaviness questionnaire
Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
Measured: 6 months post operative
Disfigurement questionnaire
Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
Measured: 6 months post operative
size of venous malformation
it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
Measured: 6 months post operative
Degree of satisfaction
It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Oct 2018
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous MalformationStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walied Khereba, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586919
- Sponsor's protocol ID
- Venous Malformation
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol
- ClinicalTrials.gov ID
- NCT05586919
- Acronym / sponsor ID
- Venous Malformation
- Conditions
- Venous Malformation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Oct 2022 (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.
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Puncture Repair / Ethanol | Active comparator | Procedure: Direct Puncture Repair / Ethanol |
| Direct Puncture Repair / Polidocanol | Active comparator | Procedure: Direct Puncture Repair / Polidocanol |
Who may qualify
- Ages
- 18 months to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with venous malformation of both genders and age above one year.
Key exclusion criteria (6 listed)
- Age below one year.
- Patients had any other vascular malformations.
- Indication for contrast material or Alcohol and polidocanol injection.
- Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
- Pulmonary embolism.
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 |
|---|---|---|
| Direct Puncture Repair / EthanolEthanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair | Procedure or surgery | Direct Puncture Repair / Ethanol |
| Direct Puncture Repair / PolidocanolPolidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair | Procedure or surgery | Direct Puncture Repair / Polidocanol |
Primary outcome
Heaviness questionnaire
Time frame: 6 months post operative
Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
Disfigurement questionnaire
Time frame: 6 months post operative
Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
size of venous malformation
Time frame: 6 months post operative
it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
Degree of satisfaction
Time frame: 6 months post operative
It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.
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 19 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Puncture Repair / Ethanol and Direct Puncture Repair / Polidocanol in people with Venous Malformation, run by Al-Azhar University at 1 site in Egypt.
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 6 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 19 Oct 2022. 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 Egypt. 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?
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?
Heaviness questionnaire (time frame: 6 months post operative). The study lists 4 primary outcomes in all. 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 19 Oct 2022.