Bowel Cancer, Bowel Diseases, Inflammatory, Rectal Bleeding
Conditions
Keywords
endoscopy, digital, examination, primary care
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.
Detailed description
All clinicians performing investigations with the LumenEye will undergo training and quality assurance assessment. The first 5 procedures will be performed with a proctor to ensure that this is performed safely using appropriate PPE according to Public Health England Recommendations. The primary study site will be based at Imperial College NHS trust which is a recognized National Bowel Cancer Screening (NBCS) Centre of excellence. The Imperial endoscopy suite performs over 10,000 endoscopic procedures each year. All patients enrolled into the study will be asked to have a glycerine suppository prior to the examination. They will be examined by the primary care physician in the clinic as per a standard rigid sigmoidoscopy assessment. Physicians may take biopsies if required but only if the physician feels this is warranted for clinical use. There is no requirement for research specimens in this study. All doctors using the LumenEye will asked to record images showing standard anatomical locations including: 1. The rectosigmoid junction 2. Each rectal haustral fold 3. Exit from the rectum. Videos will also be recorded for any pathology identified. Virtual clinics will be coordinated by the CI and Co-Is. During these clinics, a secondary care physician or surgeon will be available to discuss the case with the GP. These could be performed in real time with the patient present during a live examination or they could be performed retrospectively as part of a multidisciplinary team meeting. Clinicians will be asked to provide qualitative feedback data with each use concerning device performance. This will be in the form of a short questionnaire, split into technical performance, views achieved, diagnostic yield, quality of the telemedicine interaction, patient outcome (discharged or referred to formal endoscopy) and adverse events. Patient feedback will be requested through a validated questionnaire.. All clinicians providing advice and guidance via CHiP will be asked to provide data on the quality of the views, the stability of the platform and to provide information on the diagnosis. All data pertaining to follow up colonoscopy or flexible sigmoidoscopy will be used as a comparator group for a diagnostic sensitivity / specificity analysis.
Interventions
The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience of LumenEye Examination | On the day of examination | Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale |
| Clinician Experience of LumenEye Examination | On the day of examination | Assessing the the positive response rate by examining clinicians to their overall experience and certainty of diagnosis for each examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
This was an observational feasibility study with no exclusions after recruitment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 114 |
| Total | 114 |
Baseline characteristics
| Characteristic | Observational Cohort | — |
|---|---|---|
| Age, Continuous | 53 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 46 Participants | — |
| Sex: Female, Male Male | 68 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
Primary
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
Time frame: On the day of examination
Population: Clinician reports on each examination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Cohort | Clinician Experience of LumenEye Examination | Very confident in suspected diagnosis | 56 percentage of clinician experience |
| Observational Cohort | Clinician Experience of LumenEye Examination | Reasonably confident in suspected diagnosis | 35 percentage of clinician experience |
| Observational Cohort | Clinician Experience of LumenEye Examination | Visualisation of rectosigmoid junction with LumenEye | 89 percentage of clinician experience |
Primary
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
Time frame: On the day of examination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Cohort | Patient Experience of LumenEye Examination | Examination was more comfortable than expected | 75 percentage of participants |
| Observational Cohort | Patient Experience of LumenEye Examination | Examination more comfortable than previous rigid sigmoidoscopy | 67 percentage of participants |
| Observational Cohort | Patient Experience of LumenEye Examination | Examination in the community more convenient than in hospital | 95 percentage of participants |
| Observational Cohort | Patient Experience of LumenEye Examination | Sharing over images over CHiP is beneficial to care | 94 percentage of participants |
| Observational Cohort | Patient Experience of LumenEye Examination | Comfortable with sharing of images with secondary care | 97 percentage of participants |
| Observational Cohort | Patient Experience of LumenEye Examination | Reassured that images are reviewed by secondary care | 98 percentage of participants |
Secondary
Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation
To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Cohort | 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 |
| Observational Cohort | 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 |