Perianal FistulasPhase 2NCT01462747
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
A Phase 2 study testing KULIST in people with Perianal Fistulas, run by Nordic Drugs AB at 2 sites in Sweden.
Trial summary
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perianal Fistulas
- What is being tested?
- KULIST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSweden
- Study dates
- Dec 2011to Jan 2013
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
- Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
- Superficial fistula involving a part of the external sphincter muscle
- Age: ≥18 years and ≤ 75 years
- Informed consent and/or Letter of Authority (as applicable) obtained
Who cannot join
- Inflammatory Bowel Disease (IBD)
- Rectovaginal fistulas
- Rectourethral fistulas
- Rectovesical fistulas
- Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
- Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
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- Any surgical treatment for perianal fistulas
- Colorectal and/or anal malignancy
- Other malignancy requiring active treatment
- Subcutaneous fistulas not involving any part of the external sphincter
- Other diseases which as per the investigator's opinion should be contraindicated
- Subjects who are not able to complete study procedures as per the investigator's opinion
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Malmö University Hospital Dept of Surgery
Malmö, Malmö, 205 02
Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Stockholm, Stockholm County, 182 88
About this study
Official title: An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
Read the detailed description
Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.
Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.
- Conditions
- Perianal Fistulas
- Being tested
- KULIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KULISTDevice
Twice daily dosing for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| KULIST | Experimental | Medical Device, Activated carbon Receives: Device: KULIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of fistula healing, change from baseline
Fistula assessed as healed/not healed
Measured: week 8 and 24
Secondary outcomes (3)
Anal ultrasonography, change from baseline
Healed/not healed
Measured: week 8 and 24
Patient assessment of Symptoms and Impact on Daily Function, change from baseline
By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed
Measured: week 8 and 24
Safety, change from baseline
Standard collection of adverse events and adverse device effects.
Measured: week 2, 8, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Drugs AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Måns Bohe, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462747
- Sponsor's protocol ID
- KULIST-001
- Status last verified
- Feb 2013
- First submitted
- 21 Oct 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas
- ClinicalTrials.gov ID
- NCT01462747
- Acronym / sponsor ID
- KULIST-001
- Conditions
- Perianal Fistulas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nordic Drugs ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Oct 2011 (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.
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
Detailed description
Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.
Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KULIST | Experimental | Device: KULISTMedical Device, Activated carbon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
- Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
- Superficial fistula involving a part of the external sphincter muscle
- Age: ≥18 years and ≤ 75 years
- Informed consent and/or Letter of Authority (as applicable) obtained
Key exclusion criteria (12 listed)
- Inflammatory Bowel Disease (IBD)
- Rectovaginal fistulas
- Rectourethral fistulas
- Rectovesical fistulas
- Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
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 |
|---|---|---|
| KULISTTwice daily dosing for 8 weeks | Device | KULIST |
Primary outcome
Clinical evaluation of fistula healing, change from baseline
Time frame: week 8 and 24
Fistula assessed as healed/not healed
3 secondary outcomes
Anal ultrasonography, change from baseline
Time frame: week 8 and 24
Patient assessment of Symptoms and Impact on Daily Function, change from baseline
Time frame: week 8 and 24
Safety, change from baseline
Time frame: week 2, 8, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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.
Måns Bohe, MD, PhD principal investigator
Skane University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KULIST in people with Perianal Fistulas, run by Nordic Drugs AB at 2 sites in Sweden.
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 12 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: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of fistula healing, change from baseline (time frame: week 8 and 24). 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 13 Feb 2013.