CYSTIC MALFORMATIONPhase 4OK432NCT01699347
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
A Phase 4 study testing Intracystic injection of OK432 under US guiding in people with CYSTIC MALFORMATION, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- CYSTIC MALFORMATION
- What is being tested?
- Intracystic injection of OK432 under US guiding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
- ONLY IN THE HEAD AND NECK AREA
- TIME FROM OPERATION AT LEAST 6 MONTHS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Carmel Medical Center
Haifa, 34362
Raanan Cohen-Kerem, MD, +97248250279, raanan@clalit.org.il
Raanan Cohen-Kerem, MD
About this study
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.
Read the 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
- Conditions
- CYSTIC MALFORMATION
- Being tested
- Intracystic injection of OK432 under US guiding
- Keywords
- OK432, CYSTIC MALFORMATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracystic injection of OK432 under US guidingDrug
Also called OK432 (Picibanil)
Intracystic injection of OK432 under US guiding
| Study group | Role | What they receive |
|---|---|---|
| OK432 | Experimental | Intracystic injection of OK432 under US guiding Receives: Drug: Intracystic injection of OK432 under US guiding |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
Measured: 4 years
Secondary outcomes (1)
TREATMENT SAFETY BY no. of participants with adverse events
Measured: 4 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CYSTIC MALFORMATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raanan Cohen-Kerem, MD, Principal investigator, Carmel Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699347
- Sponsor's protocol ID
- CMC-11-0059-CTIL
- Acronym
- OK432
- Status last verified
- Nov 2013
- First submitted
- 19 Aug 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
- ClinicalTrials.gov ID
- NCT01699347
- Acronym / sponsor ID
- OK432 / CMC-11-0059-CTIL
- Conditions
- CYSTIC MALFORMATION
- Keywords
- OK432, CYSTIC MALFORMATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OK432 | Experimental | Drug: Intracystic injection of OK432 under US guidingIntracystic injection of OK432 under US guiding |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
- ONLY IN THE HEAD AND NECK AREA
- TIME FROM OPERATION AT LEAST 6 MONTHS
Key exclusion criteria (8 listed)
- penicillin allergy
- pregnancy
- familial history of RF
- Post streptococcal glomerulonephritis
- Background illness-heart, kidney, lungs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracystic injection of OK432 under US guidingAlso: OK432 (Picibanil)Intracystic injection of OK432 under US guiding | Drug | OK432 |
Primary outcome
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence
Time frame: 4 years
1 secondary outcome
TREATMENT SAFETY BY no. of participants with adverse events
Time frame: 4 YEARS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raanan Cohen-Kerem, MD principal investigator
Carmel Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracystic injection of OK432 under US guiding in people with CYSTIC MALFORMATION, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.