NCT06437158 Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
| NCT ID | NCT06437158 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | West China Hospital |
| Condition | Lymphatic Malformation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-03-08 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2023-03-08 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.
Eligibility Criteria
Inclusion Criteria: * Male or female participants less than 14 years of age at the time of informed consent/assent form was signed. * Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them. * Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy. Exclusion Criteria: * Penicillin allergy. * Vascular tumors or combined vascular malformations. * Participants who may have had surgical or sclerotherapy treatment by other hardeners. * LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06437158 clinical trial?
This trial is open to participants of all sexes, up to 14 Years, studying Lymphatic Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06437158 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06437158 currently recruiting?
Yes, NCT06437158 is actively recruiting participants. Contact the research team at jijiyuanyuan@163.com for enrollment information.
Where is the NCT06437158 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06437158 clinical trial?
NCT06437158 is sponsored by West China Hospital. The trial plans to enroll 200 participants.