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

LumenEye During CovID-19 (LuCID Study)

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.

Study Overview

• Status: Completed
• Conditions: Bowel Cancer; Rectal Bleeding; Bowel Diseases, Inflammatory
• Intervention / Treatment: Device: LumenEye X1 digital rectoscope

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational cohort; 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; The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience of LumenEye Examination	Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale	On the day of examination
Clinician Experience of LumenEye Examination	Assessing the the positive response rate by examining clinicians to their overall experience and certainty of diagnosis for each examination	On the day of examination

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.	Diagnostic accuracy of the LumenEye examination to be compared with subsequent investigations completed by the time of analysis (2-9 months after study examination).

Collaborators and Investigators

• Sponsor: Imperial College London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2020
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: primary care; endoscopy; digital; examination
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: IRAS 285758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No