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

NCT05043363 | Completed Results

• 1 other identifier: IRAS 285758
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Cancer; Bowel Diseases, Inflammatory; Rectal Bleeding

Keywords

endoscopy; digital; examination; primary care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation

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

Study Arms (1)

Observational cohort

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 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

Interventions

LumenEye X1 digital rectoscope DEVICE

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

Observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• WW patients referred to a colorectal clinic
• Known IBD patients with flare symptoms
• Patients with a suspected new diagnosis of IBD

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35728817 RESULT

MeSH Terms

Conditions

Intestinal Neoplasms; Inflammatory Bowel Diseases; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Gastroenteritis; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr James Kinross
• Organization: Imperial College London

j.kinross@imperial.ac.uk

02033121947

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 14, 2021
• Study Start: November 14, 2020
• Primary Completion: June 5, 2021
• Study Completion: September 1, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

GB (1)