NCT04274010: PAN-ICS

PANenteric Crohn's Capsule Versus Ileo-Colonoscopy and Scan Study

Terminated NA Last updated 28 November 2023

What this trial tests

NA trial testing PillCamTM Crohn's capsule in Crohn Disease in 38 participants. Terminated before completion.

Timeline

15 December 2020

Primary endpoint
21 October 2022

21 October 2022

Quick facts

Lead sponsor	South Tyneside and Sunderland NHS Foundation Trust
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	38
Start date	15 December 2020
Primary completion	21 October 2022
Estimated completion	21 October 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• PillCamTM Crohn's capsule
• Magnetic resonance enterography
• Ileo-colonoscopy

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

South Tyneside and Sunderland NHS Foundation Trust

Who can join

Adults 18 to 75, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 is active, namely ileo-colonoscopy (camera examination of the large bowel, IC) and a scan of the small bowel (MRE). Together, these tests help determine if the patients' symptoms are due to CD, which is important as the medication to heal the bowel is strong. But, these investigations are uncomfortable, embarrassing, time-consuming and involve hospital visits to two separate departments.

A new test involves swallowing a miniature camera, the size of a large vitamin pill (PillCam™ Crohn's (PCC)) that video-records the lining of the small and large bowel. Images are sent to a recorder worn over the tummy. The investigators aim to find out if the PCC capsule delivers a single test that is comparable to current tests (IC+MRE) for patients with CD.

125 patients with CD referred for IC+MRE will be recruited from 3 NHS hospitals. Each patient will undergo all three tests (IC+MRE and PCC). As there is a small risk of the capsule getting stuck (up to 3 in 100 patients), all patients will have a "dummy" capsule to check that the "real" capsule can travel safely through the bowel. If successful (checked with a handheld scanner and CT scan if required), patients proceed to PCC. Patients will receive bowel preparation (a drink to clean the bowel) prior to IC and PCC.

The investigators will compare the findings of all three tests. The investigators will interview patients to find out their experiences to inform the way the test is introduced into practice. When consulted, local patients with CD felt the research question is extremely important and all preferred having one non-invasive test over two invasive and uncomfortable tests.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.