Clinical trial NCT03241368: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Irritable Bowel Disease
IBD
Mucosal Disease
Crohn's
Inflammatory Bowel Disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Patient Satisfaction
timeFrame: After completion of final procedure, either the same day or by the next business day following procedure completion.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic (Scottsdale, AZ)
state: Arizona
city: Jacksonville
country: United States
facility: Encore Borland Groover Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Children's Center for Digestive Healthcare
state: Georgia
city: Maywood
country: United States
facility: Loyola University - Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic (Rochester, MN)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Morristown
country: United States
facility: Atlantic Health (Morristown)
state: New Jersey
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Suffolk
country: United States
facility: Virginia Gastroenterology Institute
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus - Universitatskliniken Wein
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
state: Ramat Gan
Study officials:
affiliation: Mayo
name: David Bruining, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruining DH, Oliva S, Fleisher MR, Fischer M, Fletcher JG; BLINK study group. Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study. BMJ Open Gastroenterol. 2020 Jun;7(1):e000365. doi: 10.1136/bmjgast-2019-000365.