NCT01699347

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A cohort study, before the injection all the patients in the study will go through: 1. CT/MRI 2. US to estimate the cyst size 3. CBC, PT, PTT, INR, ASLO 4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral. The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in. After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia. Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo. Long term follow-up: 6 months, 1 year, 2 years

Conditions

• CYSTIC MALFORMATION

Interventions

Type	Name	Description
DRUG	Intracystic injection of OK432 under US guiding	Intracystic injection of OK432 under US guiding

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-01-01
• Completion: 2016-01-01
• First posted: 2012-10-03
• Last updated: 2013-12-02

Locations

1 site across 1 country: Israel