Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas
1 other identifier
interventional
28
1 country
2
Brief Summary
The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 31, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 13, 2013
February 1, 2013
6 months
October 21, 2011
February 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical evaluation of fistula healing, change from baseline
Fistula assessed as healed/not healed
week 8 and 24
Secondary Outcomes (3)
Anal ultrasonography, change from baseline
week 8 and 24
Patient assessment of Symptoms and Impact on Daily Function, change from baseline
week 8 and 24
Safety, change from baseline
week 2, 8, 24
Study Arms (1)
KULIST
EXPERIMENTALMedical Device, Activated carbon
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordic Drugs ABlead
Study Sites (2)
Malmö University Hospital Dept of Surgery
Malmo, Malmö, 205 02, Sweden
Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Stockholm, Stockholm County, 182 88, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Måns Bohe, MD, PhD
Skane University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2011
First Posted
October 31, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2012
Study Completion
January 1, 2013
Last Updated
February 13, 2013
Record last verified: 2013-02