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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (AE). 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.

Official Title
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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

Conditions
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Crohn Disease

Intervention / Treatment
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* Device: Capsule Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent. Subject is ≥ 18 years of age Subject is willing and able to comply with all aspects of treatment and evaluation schedule. Subject has known CD and a recent history (within last 2 years) of mucosal disease (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information. Exclusion Criteria: Subject has indeterminate, ulcerative, antibiotic-associated colitis. Subject has stool positive for ova and parasite and for Clostridium difficile toxins within 3 months prior to enrollment. Subject with other known infectious cause of abdominal symptoms. Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range. Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment. Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility. Subject with suspected or known bowel obstruction, stricture (defined as unequivocal proximal upstream dilation equal ≥ 2.5 cm), or fistula. Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (≤ 100 mg daily) are acceptable and not exclusionary. Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions. Subject with cardiac pacemaker or other implanted electromedical device. Subject has an allergy or other known contraindication to the medications used in the study. Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding. Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity). Subject has a known contraindication to MRE or IC. Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study. Subject has any medical condition that would make it unsafe for them to participate, per Investigator's discretion Subject with ileostomy or colostomy, history of total or subtotal colectomy (including those with ileosigmoidostomy, and ileorectostomy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRE, Patency Capsule (if needed), CE, and IC<br>Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure. | Device: Capsule Endoscopy<br>* At baseline subject will under the PillCam Crohn's Capsule Procedure<br>* Other names: PillCam Crohn's® Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. | Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score | Baseline | 
| Sensitivity, 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 | Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score | Baseline | 
| Patient Satisfaction | Patient preference of which procedure they preferred (CE, IC or MRE plus IC) | After completion of final procedure, either the same day or by the next business day following procedure completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Disease, IBD, Mucosal Disease, Crohn's, Inflammatory Bowel Disease