LumenEye during COVID-19 (LuCID study)
Despite the challenges of Covid-19, the Lucid Study has proven a great success so far. We are pleased to announce recruitment in London, Ascot, Blackburn and the strong possibility of a Scottish site coming soon.
Design
Prospective, observational pilot study, medical device
Aims
The main hypothesis is that digital rectoscopy (using the LumenEye system) is safe and acceptable to clinicians including general practitioners and can significantly reduce the burden of endoscopy referral to and within secondary care centres.
The secondary objectives are:
- To assess the safety and acceptability of the LumenEye and CHiP system in primary and secondary care.
- To establish the clinical utility of the CHiP software system for performing remote telemedicine assessment of the rectum and colon.
- To provide pilot data for the diagnostic accuracy of the LumenEye system for colitis severity, cancer, rectal polyps, and benign disease of the rectum and anus.
Outcome measures
Primary outcome:
Both safety and patient and clinical acceptance of the LumenEye device with specialist consultation over the CHiP platform.
Secondary outcomes:
- To establish the clinical utility of the CHiP software system for performing remote telemedicine assessment of the rectum and colon.
- To provide pilot data for the diagnostic accuracy of the LumenEye system for colitis severity, cancer, rectal polyps and benign disease of the rectum and anus.
Population
Adult patients presenting to either their primary care physician or to secondary care services because of a change in bowel habit, rectal bleeding or assessment for symptoms of established or suspected ulcerative colitis
Eligibility
Patients aged 18 and over
Patients presenting to primary or secondary care settings
With any of:
- rectal bleeding
- established ulcerative colitis requiring assessment
- Positive Faecal occult blood test / Faecal immunochemical test (FIT) or faecal calprotectin
any symptom that would warrant referral on the 2WW cancer referral pathway
Duration
1 Year
Sponsor
Imperial College NHS Trust
Funded by Innovate UK