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

NCT ID: NCT01699347

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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

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CYSTIC MALFORMATION

Keywords

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OK432, CYSTIC MALFORMATION

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OK432

Intracystic injection of OK432 under US guiding

Group Type EXPERIMENTAL

Intracystic injection of OK432 under US guiding

Intervention Type DRUG

Intracystic injection of OK432 under US guiding

Interventions

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Intracystic injection of OK432 under US guiding

Intracystic injection of OK432 under US guiding

Intervention Type DRUG

Other Intervention Names

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OK432 (Picibanil)

Eligibility Criteria

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Inclusion Criteria

* LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
* ONLY IN THE HEAD AND NECK AREA
* TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria

* penicillin allergy
* pregnancy
* familial history of RF
* Post streptococcal glomerulonephritis
* Background illness-heart, kidney, lungs
* fever \> 38.5c in the op day
* URT Infection
* Family history of PANDAS
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raanan Cohen-Kerem, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center, Haifa, Israel

Locations

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Department of Otolaryngology, Carmel Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Raanan Cohen-Kerem, MD

Role: primary

Other Identifiers

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CMC-11-0059-CTIL

Identifier Type: -

Identifier Source: org_study_id