LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19

Study Overview
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Brief Summary
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The LumenEye scope and CHiP platform will be piloted in a number of clinical settings including remote colorectal clinics. The rationale is to perform an initial pilot study to determine the clinical utility of the LumenEye device for use in primary and secondary care settings. The main hypothesis is that digital rectoscopy is safe and acceptable to clinicians including general practitioners and can significantly reduce the burden of endoscopy referral to and within secondary care centres.

Detailed Description
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All clinicians performing investigations with the LumenEye will undergo training and quality assurance assessment. The first 5 procedures will be performed with a proctor to ensure that this is performed safely using appropriate PPE according to Public Health England Recommendations. The primary study site will be based at Imperial College NHS trust which is a recognized National Bowel Cancer Screening (NBCS) Centre of excellence. The Imperial endoscopy suite performs over 10,000 endoscopic procedures each year. All patients enrolled into the study will be asked to have a glycerine suppository prior to the examination. They will be examined by the primary care physician in the clinic as per a standard rigid sigmoidoscopy assessment. Physicians may take biopsies if required but only if the physician feels this is warranted for clinical use. There is no requirement for research specimens in this study. All doctors using the LumenEye will asked to record images showing standard anatomical locations including: The rectosigmoid junction Each rectal haustral fold Exit from the rectum. Videos will also be recorded for any pathology identified. Virtual clinics will be coordinated by the CI and Co-Is. During these clinics, a secondary care physician or surgeon will be available to discuss the case with the GP. These could be performed in real time with the patient present during a live examination or they could be performed retrospectively as part of a multidisciplinary team meeting. Clinicians will be asked to provide qualitative feedback data with each use concerning device performance. This will be in the form of a short questionnaire, split into technical performance, views achieved, diagnostic yield, quality of the telemedicine interaction, patient outcome (discharged or referred to formal endoscopy) and adverse events. Patient feedback will be requested through a validated questionnaire.. All clinicians providing advice and guidance via CHiP will be asked to provide data on the quality of the views, the stability of the platform and to provide information on the diagnosis. All data pertaining to follow up colonoscopy or flexible sigmoidoscopy will be used as a comparator group for a diagnostic sensitivity / specificity analysis.

Official Title
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LumenEye During CovID-19 (LuCID Study)

Conditions
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Bowel Cancer, Bowel Diseases, Inflammatory, Rectal Bleeding

Intervention / Treatment
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* Device: LumenEye X1 digital rectoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 and over Patients with any of the following: Positive Faecal occult blood test / Faecal immunochemical test (FIT) Positive faecal calprotectin. Established history of polyps and/or adenomas 2WW patients referred to a colorectal clinic Known IBD patients with flare symptoms Patients with a suspected new diagnosis of IBD Exclusion Criteria: Inability to consent Inability to communicate effectively in English Pregnancy Unfit for bowel preparation Anal stricture Allergy to plastic Inability to lie flat for more than 10 minutes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational cohort<br>Patients with an established diagnosis of inflammatory bowel disease who have been identified as being 'at risk' by either their secondary care doctor or GP and now require endoscopic assessment for ongoing disease symptoms but are unable to access endoscopy services urgently. Patients presenting directly to their GP practice with symptoms of anorectal disease (e.g. rectal bleeding or pain) or symptoms that would warrant referral to a hospital under a 2WW appointment according to NICE criteria Recruited patients will undergo rectal examination in primary care with the LumenEye X1 with either contemporaneous or retrospective image review by a secondary care clinician. This will require a glycerine suppository to be administered. Patient feedback will be sought with a post-procedural questionnaire. | Device: LumenEye X1 digital rectoscope<br>* The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience of LumenEye examination | Assessing the percentage of patients with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale | 1 year | 
| Clinician experience of LumenEye examination | Assessing the percentage of clinicians with positive answers to their overall experience and certainty of diagnosis for each examination | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the LumenEye for the detection of rectal pathology including tumour, polyps and inflammation | To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, digital, examination, primary care