Clinical trial · Observational
LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19
LumenEye During CovID-19 (LuCID Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Cancer | Malignant Intestinal Neoplasm | ALIAS | 0.90 |
| Bowel Diseases, Inflammatory | — | UNRESOLVED | — |
| Rectal Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LumenEye X1 digital rectoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational cohort
- description
- 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.
- interventionNames
- Device: LumenEye X1 digital rectoscope
Primary outcomes (2)
- measure
- Patient Experience of LumenEye Examination
- timeFrame
- On the day of examination
- description
- Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLewis 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