Crohn's DiseaseNCT01074580
Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease
An observational study of Crohn's Disease, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.
Who may be able to join
- Deterioration of Crohn's disease
- CDAI>150
- Treated with systemic steroids or TNF alfa inhibitors
- Lesion found on ultrasound
Who cannot join
- Disease location not reachable with ileocolonoscopy
- Pregnancy
- Acute coronary disease
- Unstable coronary disease
- Previous allergic reaction to SonoVue or its components
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Medicine, Haukeland University Hospital
Bergen, Hordaland, 5021
About this study
Official title: High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease
The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, sonography, contrast enhanced ultrasound
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Deterioration, Crohn's disease | Patients > 18 years old with a deterioration of Crohn's disease defined by CDAI >150 and requiring treatment with systemic steroids or TNF alfa inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission defined by Crohns disease activity index (CDAI)<150
Measured: 52 weeks from inclusion
Secondary outcomes (2)
Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)
Measured: 52 weeks
Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Did not get enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Abbott
- Responsible party
- Sponsor
- Investigators
- Trygve Hausken, PhD, Study director, Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074580
- Sponsor's protocol ID
- 22209
- Status last verified
- Jan 2016
- First submitted
- 23 Feb 2010
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease
- ClinicalTrials.gov ID
- NCT01074580
- Acronym / sponsor ID
- 22209
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, sonography, contrast enhanced ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Did not get enough patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Abbott
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Feb 2010 (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 purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deterioration, Crohn's disease | – | –Patients > 18 years old with a deterioration of Crohn's disease defined by CDAI >150 and requiring treatment with systemic steroids or TNF alfa inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.
Key inclusion criteria (4 listed)
- Deterioration of Crohn's disease
- CDAI>150
- Treated with systemic steroids or TNF alfa inhibitors
- Lesion found on ultrasound
Key exclusion criteria (5 listed)
- Disease location not reachable with ileocolonoscopy
- Pregnancy
- Acute coronary disease
- Unstable coronary disease
- Previous allergic reaction to SonoVue or its components
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
Remission defined by Crohns disease activity index (CDAI)<150
Time frame: 52 weeks from inclusion
2 secondary outcomes
Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)
Time frame: 52 weeks
Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Did not get enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Trygve Hausken, PhD study director
Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
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's Disease, run by Haukeland University Hospital at 1 site in Norway.
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 4 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: stopped early, as of the sponsor's last update on 26 Jan 2016. 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 Norway. 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?
The study was stopped early (reason given: Did not get enough patients). Results are not available in the source record.
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?
Remission defined by Crohns disease activity index (CDAI)<150 (time frame: 52 weeks from inclusion). 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 26 Jan 2016.