Actively Recruiting

Phase 2
Age: 0 - 14Years
All Genders
NCT06437158

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Led by West China Hospital · Updated on 2024-06-03

200

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Who Can Participate

Age: 0 - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

Y

Yi Ji, Ph.D.

CONTACT

M

Min Yang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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