Suspended

OK432Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

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What is being tested

Intracystic injection of OK432 under US guiding

Drug
Who is being recruted

From 1 to 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorCarmel Medical Center
Study ContactRaanan Cohen-Kerem, MDMore contacts
Last updated: December 2, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

A cohort study, before the injection all the patients in the study will go through: CT/MRI US to estimate the cyst size CBC, PT, PTT, INR, ASLO 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

NCT01699347
Principal SponsorCarmel Medical Center
Study ContactRaanan Cohen-Kerem, MDMore contacts
Last updated: December 2, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC
ONLY IN THE HEAD AND NECK AREA
TIME FROM OPERATION AT LEAST 6 MONTHS
8 exclusion criteria prevent from participating
Background illness-heart, kidney, lungs
Family history of PANDAS
Post streptococcal glomerulonephritis
URT Infection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intracystic injection of OK432 under US guiding

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Otolaryngology, Carmel Medical Center

Haifa, IsraelOpen Department of Otolaryngology, Carmel Medical Center in Google Maps
SuspendedOne Study Center