Crohn DiseaseNCT00653094
An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease
A study testing Halevy kit in people with Crohn Disease and Fistula, run by ResQ Medical Ltd at 1 site in Israel.
Trial summary
Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Fistula
- What is being tested?
- Halevy kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Aug 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female age greater than 18
- Patients suffering from Crohn's disease
- Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug
- Able and willing to sign an informed consent
- Patient will be available for follow up.
Who cannot join
- Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
- Known immunodeficiency.
- Known allergy to fibrin glue or one of its components.
- An undrained perianal abscess, diagnosed by a physical examination or imaging methods.
- Known Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Eran Mr Goldin, Prof contact
Haim Mr Halevi, Dr. contact
Israel1 site
Hadassah medical center
Jerusalem
Eran Mr Goldin, Prof
Eran dr Goldin, Prof
About this study
Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.
- Conditions
- Crohn Disease, Fistula
- Being tested
- Halevy kit
- Keywords
- crohn, fistula, surgery, fibrin glue, seton drainage
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halevy kitDevice
the use of Halevy kit in Crohn patients with Fistulas
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Device: Halevy kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated
Measured: after sugery
Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated
Measured: after surgery
Success in inserting a draining Seton into the fistula tract by the Halevy kit
Measured: after surgery
Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated
Measured: after surgery
Secondary outcomes (3)
Control of sphincter will be evaluated by -the Cleveland continence score
Measured: after follow up
Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.
Measured: after follow up
Healing of the fistula will be evaluated by a physical examination
Measured: after follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResQ Medical Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Eran MR Goldin, Prof, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653094
- Sponsor's protocol ID
- H.K.prot.02-03-08
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00653094
- Acronym / sponsor ID
- H.K.prot.02-03-08
- Conditions
- Crohn Disease, Fistula
- Keywords
- crohn, fistula, surgery, fibrin glue, seton drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ResQ Medical LtdUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 4 Apr 2008 (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.
Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Device: Halevy kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female age greater than 18
- Patients suffering from Crohn's disease
- Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug
- Able and willing to sign an informed consent
- Patient will be available for follow up.
Key exclusion criteria (5 listed)
- Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
- Known immunodeficiency.
- Known Alcohol or drug abuse
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 |
|---|---|---|
| Halevy kitthe use of Halevy kit in Crohn patients with Fistulas | Device | A |
Primary outcome
Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated
Time frame: after sugery
Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated
Time frame: after surgery
Success in inserting a draining Seton into the fistula tract by the Halevy kit
Time frame: after surgery
Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated
Time frame: after surgery
3 secondary outcomes
Control of sphincter will be evaluated by -the Cleveland continence score
Time frame: after follow up
Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.
Time frame: after follow up
Healing of the fistula will be evaluated by a physical examination
Time frame: after follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2008.
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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.
Eran Mr Goldin, Prof contact
Haim Mr Halevi, Dr. contact
Eran MR Goldin, Prof principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halevy kit in people with Crohn Disease and Fistula, run by ResQ Medical Ltd 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 5 inclusion and 5 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 4 Apr 2008. 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.
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?
Contact Eran Mr Goldin, Prof (02-6776848), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated (time frame: after sugery). The study lists 4 primary outcomes in all. 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 4 Apr 2008.