Cohort Prospective Study of Children With Head and Neck C... | NCT01699347

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

NCT01699347

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Dec 2, 2013Estimated

Enrollment

5Estimated

Phase

Phase 4

Conditions

CYSTIC MALFORMATION

Interventions

Intracystic injection of OK432 under US guiding

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Aug 19, 2012

First Submission Date that Met QC Criteria

Sep 30, 2012

First Posted Date

Oct 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2013

Last Update Posted Date

Dec 2, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OK432	Experimental	Intracystic injection of OK432 under US guiding	Drug: Intracystic injection of OK432 under US guiding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intracystic injection of OK432 under US guiding	Drug	Intracystic injection of OK432 under US guiding	OK432

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence		4 years

Secondary Outcomes

Measure	Description	Time Frame
TREATMENT SAFETY BY no. of participants with adverse events		4 YEARS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raanan Cohen-Kerem, MD	Carmel Medical Center, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology, Carmel Medical Center	Recruiting	Haifa		34362	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D010844	Picibanil

Ancestor Terms

ID	Term
D001688	Biological Products
D045424	Complex Mixtures

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