Vascular MalformationsPhase 4NCT07728825
Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck
A Phase 4 study testing Bleomycin (Bleocel 15) in people with Vascular Malformations and Venous Malformation, run by University Of Anbar at 3 sites in Iraq.
Trial summary
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Vascular Malformations, Venous Malformation, Lymphatic Malformation
- What is being tested?
- Bleomycin (Bleocel 15)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesIraq
- Study dates
- 25 Aug 2025to 26 Apr 2026
- Phase
- Phase 4
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age older than one year
- Clinically and radiologically confirmed low-flow vascular malformation of the head and neck
- No prior bleomycin therapy
- Medically fit for outpatient intervention
Who cannot join
- High-flow vascular malformation
- Pregnancy or lactation
- Documented hypersensitivity to bleomycin
- Pre-existing pulmonary or hepatic disease
- Bleeding disorder or current anticoagulant use
- Renal impairment (serum creatinine > 1.5 mg/dL or estimated glomerular filtration rate < 60 mL/min/1.73 m²)
- Active infection at or near the treatment site
Trial locations and contacts
3 sites in 1 country.
Iraq3 sites
Al-Fallujah Teaching Hospital
Fallujah, Al-Anbar Governorate, 54001
Al-Najaf Al-Ashraf Teaching Hospital
Najaf, Najaf, 54001
Al-Sadr Teaching Hospital
Najaf, Najaf, 54001
About this study
Official title: Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Read the detailed description
Patients with clinically and radiologically confirmed low-flow vascular malformations of the head and neck were enrolled consecutively. Bleomycin was diluted to 3 mg/mL and injected intralesionally at multiple points, with a maximum of 15 mg per session and up to four sessions at three- to four-week intervals. Needle selection was guided by lesion depth, with ultrasound guidance used for deeper lesions. Lesion dimensions (length, width, depth) were measured by a single trained operator at each site; volume was calculated using the prolate ellipsoid formula (pi/6 x L x W x D), or by MRI-based volumetric segmentation for irregular multilocular lesions. Clinical response was graded using the modified Achauer scale. Adverse events were graded using CTCAE version 5.0, and peripheral oxygen saturation was monitored during and after each procedure.
- Being tested
- Bleomycin (Bleocel 15)
- Keywords
- Bleomycin, Sclerotherapy, Head and Neck, Iraq
- Medical subject headings
- Vascular Malformations, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin (Bleocel 15)Drug
Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional bleomycin sclerotherapy | Experimental | All participants received intralesional bleomycin sclerotherapy. Receives: Drug: Bleomycin (Bleocel 15) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in lesion volume
Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume.
Measured: Baseline to 4 weeks after the final treatment session
Secondary outcomes (1)
Incidence and severity of adverse events
Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety
Measured: From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Aug 2025
- Primary completion16 Apr 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Tawfeeq Amoori, University Of Anbar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728825
- Sponsor's protocol ID
- UOA-COD-OMFS-173
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq
- ClinicalTrials.gov ID
- NCT07728825
- Acronym / sponsor ID
- UOA-COD-OMFS-173
- Keywords
- Bleomycin, Sclerotherapy, Head and Neck, Iraq
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 27 Jul 2026 (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.
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Detailed description
Patients with clinically and radiologically confirmed low-flow vascular malformations of the head and neck were enrolled consecutively. Bleomycin was diluted to 3 mg/mL and injected intralesionally at multiple points, with a maximum of 15 mg per session and up to four sessions at three- to four-week intervals. Needle selection was guided by lesion depth, with ultrasound guidance used for deeper lesions. Lesion dimensions (length, width, depth) were measured by a single trained operator at each site; volume was calculated using the prolate ellipsoid formula (pi/6 x L x W x D), or by MRI-based volumetric segmentation for irregular multilocular lesions. Clinical response was graded using the modified Achauer scale. Adverse events were graded using CTCAE version 5.0, and peripheral oxygen saturation was monitored during and after each procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intralesional bleomycin sclerotherapy | Experimental | Drug: Bleomycin (Bleocel 15)All participants received intralesional bleomycin sclerotherapy. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than one year
- Clinically and radiologically confirmed low-flow vascular malformation of the head and neck
- No prior bleomycin therapy
- Medically fit for outpatient intervention
Key exclusion criteria (7 listed)
- High-flow vascular malformation
- Pregnancy or lactation
- Documented hypersensitivity to bleomycin
- Pre-existing pulmonary or hepatic disease
- Bleeding disorder or current anticoagulant use
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 |
|---|---|---|
| Bleomycin (Bleocel 15)Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions. | Drug | Intralesional bleomycin sclerotherapy |
Primary outcome
Percentage reduction in lesion volume
Time frame: Baseline to 4 weeks after the final treatment session
Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume.
1 secondary outcome
Incidence and severity of adverse events
Time frame: From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bleomycin (Bleocel 15) in people with Vascular Malformations and Venous Malformation, run by University Of Anbar at 3 sites in Iraq.
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 4 inclusion and 7 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iraq. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage reduction in lesion volume (time frame: Baseline to 4 weeks after the final treatment session). 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 27 Jul 2026.