Trial Outcomes & Findings for LuCID - Investigating the Use of a Novel Digital Rectoscope for Community Examinations During COVID-19 (NCT NCT05043363)
NCT ID: NCT05043363
Last Updated: 2024-09-19
Results Overview
Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale
Recruitment status
COMPLETED
Target enrollment
114 participants
Primary outcome timeframe
On the day of examination
Results posted on
2024-09-19
Participant Flow
Patients were recruited from general practice or from urgent suspected colorectal cancer referral waiting lists held in secondary care. 114 patients were enrolled in the study from five NHS regions between November 2020 and June 2021.
This was an observational feasibility study with no exclusions after recruitment.
Participant milestones
| Measure |
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.
LumenEye X1 digital rectoscope: The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
|
|---|---|
|
Overall Study
STARTED
|
114
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observational Cohort
n=114 Participants
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
|
|---|---|
|
Age, Continuous
|
53 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: On the day of examinationAssessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale
Outcome measures
| Measure |
Observational Cohort
n=110 Participants
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.
LumenEye X1 digital rectoscope: The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
|
|---|---|
|
Patient Experience of LumenEye Examination
Examination was more comfortable than expected
|
75 percentage of participants
|
|
Patient Experience of LumenEye Examination
Examination more comfortable than previous rigid sigmoidoscopy
|
67 percentage of participants
|
|
Patient Experience of LumenEye Examination
Examination in the community more convenient than in hospital
|
95 percentage of participants
|
|
Patient Experience of LumenEye Examination
Sharing over images over CHiP is beneficial to care
|
94 percentage of participants
|
|
Patient Experience of LumenEye Examination
Comfortable with sharing of images with secondary care
|
97 percentage of participants
|
|
Patient Experience of LumenEye Examination
Reassured that images are reviewed by secondary care
|
98 percentage of participants
|
PRIMARY outcome
Timeframe: On the day of examinationPopulation: Clinician reports on each examination
Assessing the the positive response rate by examining clinicians to their overall experience and certainty of diagnosis for each examination
Outcome measures
| Measure |
Observational Cohort
n=110 Participants
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.
LumenEye X1 digital rectoscope: The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
|
|---|---|
|
Clinician Experience of LumenEye Examination
Very confident in suspected diagnosis
|
56 percentage of clinician experience
|
|
Clinician Experience of LumenEye Examination
Reasonably confident in suspected diagnosis
|
35 percentage of clinician experience
|
|
Clinician Experience of LumenEye Examination
Visualisation of rectosigmoid junction with LumenEye
|
89 percentage of clinician experience
|
SECONDARY outcome
Timeframe: Diagnostic accuracy of the LumenEye examination to be compared with subsequent investigations completed by the time of analysis (2-9 months after study examination).Population: Patients undergoing colonoscopy, flexible sigmoidoscopy, or CTVC after LumenEye examination.
To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy.
Outcome measures
| Measure |
Observational Cohort
n=48 Participants
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.
LumenEye X1 digital rectoscope: The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
|
|---|---|
|
Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation
Sensitivity for diagnosis of tumour, polyp or inflammation
|
90.0 Percent
|
|
Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation
Specificity for diagnosis of tumour, polyp or inflammation
|
88.9 Percent
|
Adverse Events
Observational Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place