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Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

NCT01699347 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-12-02

No results posted yet for this study

Summary

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.

Conditions

  • CYSTIC MALFORMATION

Interventions

DRUG

Intracystic injection of OK432 under US guiding

Intracystic injection of OK432 under US guiding

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Raanan Cohen-Kerem, MD · Carmel Medical Center, Haifa, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-01-31
Completion
2016-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699347 on ClinicalTrials.gov