Crohn DiseaseNCT03288961
Self Screening Tool for Crohn's Perianal Fistula
An observational study of Crohn Disease, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study aims to develop a self-screening tool for Crohn's perianal fistula. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Crohn Disease
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 1 Dec 2019
- Phase
- Observational
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Crohn's disease patients are asked to fill out survey of their perianal symptoms. Survey score is compared with MRI results as the gold standard.
Who may be able to join
- Crohn's disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
Eun Soo Kim, MD, PhD, +82-53-250-5879, dandy813@hanmail.net
About this study
Official title: Development and Validation of Patient Self-screening and Monitoring Tool for Crohn's Perianal Fistula
This study aims to develop a self-screening tool for Crohn's perianal fistula.
- Conditions
- Crohn Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal fistula
perianal fistula rate confirmed by MRI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 May 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288961
- Sponsor's protocol ID
- KNUH14
- Status last verified
- Aug 2019
- First submitted
- 19 Sep 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Patient Self-screening and Monitoring Tool for Crohn's Perianal Fistula
- ClinicalTrials.gov ID
- NCT03288961
- Acronym / sponsor ID
- KNUH14
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 20 Sep 2017 (actual)
- 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.
This study aims to develop a self-screening tool for Crohn's perianal fistula.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Crohn's disease patients are asked to fill out survey of their perianal symptoms. Survey score is compared with MRI results as the gold standard.
Key inclusion criteria (1 listed)
- Crohn's disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perianal fistula
Time frame: 1 day
perianal fistula rate confirmed by MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Kyungpook National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 13 Aug 2019. 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 South Korea. 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?
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?
Perianal fistula (time frame: 1 day). 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 Aug 2019.