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COMPLETED NA

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.

NCT03241368 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE Capsule Endoscopy

Study Locations (20)

Indiana

  • Indiana University — Indianapolis
  • Indianapolis Gastroenterology Research Foundation — Indianapolis

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland
  • The Ohio State University Medical Center — Columbus

Alabama

  • University of South Alabama — Mobile

Arizona

  • Mayo Clinic (Scottsdale, AZ) — Scottsdale

Florida

  • Encore Borland Groover Clinical Research — Jacksonville

Georgia

  • Children's Center for Digestive Healthcare — Atlanta

Illinois

  • Loyola University - Chicago — Maywood

Kansas

  • University of Kansas — Kansas City

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2017-12-21
Est. Completion 2019-06-20
Phase NA

Sponsor

Medtronic - MITG

89 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03241368

The ClinicalTrials.gov registry entry for NCT03241368 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 89 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention — of which Capsule Endoscopy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03241368 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Indiana, Ohio, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03241368 about?

NCT03241368 is a clinical study titled "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.". 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 f...

What is the current status of trial NCT03241368?

This trial is currently completed. It is a NA study. The enrollment target is 187 participants. The study started on 2017-12-21. Estimated completion is 2019-06-20.

What conditions does trial NCT03241368 study?

This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03241368?

The interventions under investigation include: Capsule Endoscopy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03241368?

This trial is sponsored by Medtronic - MITG, which has 89 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03241368 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial