search
Back to results

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

Primary Purpose

CYSTIC MALFORMATION

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Intracystic injection of OK432 under US guiding
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CYSTIC MALFORMATION focused on measuring OK432, CYSTIC MALFORMATION

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Otolaryngology, Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OK432

Arm Description

Intracystic injection of OK432 under US guiding

Outcomes

Primary Outcome Measures

evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence

Secondary Outcome Measures

TREATMENT SAFETY BY no. of participants with adverse events

Full Information

First Posted
August 19, 2012
Last Updated
November 28, 2013
Sponsor
Carmel Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01699347
Brief Title
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Acronym
OK432
Official Title
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CYSTIC MALFORMATION
Keywords
OK432, CYSTIC MALFORMATION

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OK432
Arm Type
Experimental
Arm Description
Intracystic injection of OK432 under US guiding
Intervention Type
Drug
Intervention Name(s)
Intracystic injection of OK432 under US guiding
Other Intervention Name(s)
OK432 (Picibanil)
Intervention Description
Intracystic injection of OK432 under US guiding
Primary Outcome Measure Information:
Title
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
Time Frame
4 years
Secondary Outcome Measure Information:
Title
TREATMENT SAFETY BY no. of participants with adverse events
Time Frame
4 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raanan Cohen-Kerem, MD
Organizational Affiliation
Carmel Medical Center, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raanan Cohen-Kerem, MD
Phone
+97248250279
Email
raanan@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Raanan Cohen-Kerem, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs