Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
2 other identifiers
interventional
135
1 country
1
Brief Summary
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedNovember 7, 2023
November 1, 2023
12.3 years
April 11, 2011
November 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Intesity, frequency and type of pain.
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the Visual Analog Score 0-10, 0 beingno pain,10 being maximum pain, will be used in this matter.
1 year
Study Arms (3)
Bleomycin + Fibrovein
EXPERIMENTAL1\) Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. 2\) wait 5 minutes 3\) Bleomycin 1000 iu / ml. Injected volume same as volume of Fibrovein foam.
Bleomycin
ACTIVE COMPARATORBleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.
Natrium Tetradecyl Sulphate (Fibrovein )
EXPERIMENTALFibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.
Interventions
Intralesional
Intralesional
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Venous malformation
- Must be able to fill in questionary form
- Must be able to sign informed consent form
You may not qualify if:
- Kidney disease
- Lung disease
- Pregnancy or not willing to safe contraception
- Allergy to Bleomycin or Fibrovein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo Universitetssykehus Rikshospitalet
Oslo, 0227, Norway
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andreas Abildgaard, Phd
Oslo Universitetssykehus, Rikshospitalet
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 11, 2011
First Posted
May 4, 2011
Study Start
August 1, 2011
Primary Completion
November 30, 2023
Study Completion
June 30, 2025
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share