Status:
TERMINATED
PANenteric Crohn's Capsule Versus Ileo-Colonoscopy and Scan Study
Lead Sponsor:
South Tyneside and Sunderland NHS Foundation Trust
Collaborating Sponsors:
County Durham and Darlington NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Crohn's disease (CD) is a lifelong condition affecting the small and/or large bowel, causing diarrhoea, abdominal pain and weight loss. Patients with CD receive two tests to assess if the patients' CD...
Detailed Description
Purpose and design Aims: To determine if the PillCam™ Crohn's capsule (PCC) performs similarly to ileo-colonoscopy (IC) and magnetic resonance enterography (MRE) when assessing patients with an esta...
Eligibility Criteria
Inclusion
- Age 18-75
- Established diagnosis of Crohn's disease
- Patients who have been referred for IC and MRE for CD assessment as deemed appropriate by referring clinician as part of standard care
Exclusion
- Indeterminate colitis or ulcerative colitis
- Stricturing disease - history consistent with obstruction e.g. nausea, vomiting, abdominal pain, bloating after meals or stricture seen on previous imaging
- Enteric fistulating disease based on clinical examination or previous imaging (perianal fistulae alone is allowed in the absence of anal strictures)
- Previous small bowel or colonic resection within 12 months
- Known or suspected bowel dysmotility
- Previous pelvic radiotherapy
- Insulin-treated diabetes mellitus
- Pregnancy
- Recent non-steroidal agent use within 4 weeks of study entry (excluding aspirin \<150mg per day)
- Contraindications to MRE, IC or capsule endoscopy
- Contraindications to taking bowel preparation
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04274010
Start Date
December 15 2020
End Date
October 21 2022
Last Update
November 28 2023
Active Locations (1)
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1
South Tyneside District Hospital
South Shields, Tyne and Wear, United Kingdom, NE34 0PL