Clinical trial NCT05043363: LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19
Official title: LumenEye During CovID-19 (LuCID Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Cancer
Bowel Diseases, Inflammatory
Rectal Bleeding
Keywords: endoscopy
digital
examination
primary care
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified for recruitment via two routes:

1. 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.
2. 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

Brief summary: 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: 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:

1. The rectosigmoid junction
2. Each rectal haustral fold
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Experience of LumenEye Examination
timeFrame: On the day of examination
measure: Clinician Experience of LumenEye Examination
timeFrame: On the day of examination
Secondary outcomes:
measure: Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation
timeFrame: Diagnostic accuracy of the LumenEye examination to be compared with subsequent investigations completed by the time of analysis (2-9 months after study examination).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
citation: Lewis J, Askari A, Mehta A, Razak Y, Patel P, Misra R, Tilney H, Ahmed T, Ahmed M, Syeed A, Camilleri-Brennan J, Nicholls RJ, Kinross JM. A novel digital rectoscope for the triage of lower gastrointestinal symptoms in primary care: a prospective multicentre feasibility study. BJGP Open. 2022 Sep 28;6(3):BJGPO.2022.0036. doi: 10.3399/BJGPO.2022.0036. Print 2022 Sep.