N/A
Completed N=114
LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19
Bowel Cancer · Bowel Diseases, Inflammatory · Rectal Bleeding
Source: ClinicalTrials.gov NCT05043363 ↗
Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Patient Experience of LumenEye Examination — 75; 67; 95; 94 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Experience of LumenEye Examination |
75; 67; 95; 94; 97; 98 | — |
| PRIMARY Clinician Experience of LumenEye Examination |
56; 35; 89 | — |
| SECONDARY Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation |
90.0; 88.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT05043363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.