Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease. (BLINK)
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|ClinicalTrials.gov Identifier: NCT03241368|
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : October 14, 2019
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.
The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease.
There will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Device: Capsule Endoscopy||Not Applicable|
This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known CD and mucosal disease.
A screening visit will be performed within 30 days prior to baseline procedures to assess pre-procedure eligibility. At this visit the following assessments will be performed: Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification, Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy tests.
At baseline, subjects with known CD on routine evaluation (e.g. history, physical exams, labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease based on clinical judgment based on symptoms, laboratory data or other clinical information will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel. Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events.
Subjects will be exited from the study once all Baseline Procedures have been completed and AEs resolved.
All CE videos, IC videos and MRE images will be evaluated by central readers.
The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5 years. The expected duration of each subject's participation is approximately 1 month.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease|
|Actual Study Start Date :||December 21, 2017|
|Actual Primary Completion Date :||June 20, 2019|
|Actual Study Completion Date :||June 20, 2019|
Baseline visit includes MRE procedure, PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
Device: Capsule Endoscopy
At baseline subject will under the PillCam Crohn's Capsule Procedure
Other Name: PillCam Crohn's® Capsule
- Sensitivity for detecting active CD in the small bowel and colon by CE as compared to IC plus MRE [ Time Frame: Baseline ]Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score
- Specificity, negative predictive value, and positive predictive value for active CD in the small bowel and colon by CE as compared to IC plus MRE. [ Time Frame: Baseline ]Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score
- Senstivity, specificity, negative predictive value and positive predictive value for active CD in designated bowel segments (proximal small bowel terminal ileum, and colon) by Capsule Endoscopy as compared to IC plus MRE [ Time Frame: Baseline ]Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index Score and Magnetic Resonance Index of Activity Score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241368
Show 26 Study Locations
|Principal Investigator:||David Bruining, MD||Mayo|