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.

Crohn Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241368
• Other study ID #: COVSBCC0549
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: October 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Device:
• Capsule Endoscopy
At baseline subject will under the PillCam Crohn's Capsule Procedure

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus - Universitatskliniken Wein	Vienna
Israel	Sheba Medical Center	Tel Hashomer	Ramat Gan
United States	University of Michigan	Ann Arbor	Michigan
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Children's Center for Digestive Healthcare	Atlanta	Georgia
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	Encore Borland Groover Clinical Research	Jacksonville	Florida
United States	University of Kansas	Kansas City	Kansas
United States	Loyola University - Chicago	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama
United States	Atlantic Health (Morristown)	Morristown	New Jersey
United States	Louisiana State University Health Science Center	New Orleans	Louisiana
United States	Digestive Disease Specialists Inc.	Oklahoma City	Oklahoma
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Carilion Clinic	Roanoke	Virginia
United States	Mayo Clinic (Rochester, MN)	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Mayo Clinic (Scottsdale, AZ)	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Austria,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.