Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT01347294
• Date of registration: 11/04/2011
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
• Scientific title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
• Date of first enrolment: August 2011
• Target sample size: 135
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01347294
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Norway

Contacts

• Name: Andreas Abildgaard, Phd
• Affiliation: Oslo Universitetssykehus, Rikshospitalet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of Venous malformation

- Must be able to fill in questionary form

- Must be able to sign informed consent form

Exclusion Criteria:

- Kidney disease

- Lung disease

- Pregnancy or not willing to safe contraception

- Allergy to Bleomycin or Fibrovein



Age minimum: 12 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Venous Malformation

Intervention(s)

Drug: Bleomycin + Fibrovein

Drug: Bleomycin

Drug: Fibrovein

Primary Outcome(s)

Intesity, frequency and type of pain. [Time Frame: 1 year]

Secondary ID(s)

TMF1331

1331TMF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors