Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05043363 |
Other study ID # |
IRAS 285758 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 14, 2020 |
Est. completion date |
September 1, 2021 |
Study information
Verified date |
September 2021 |
Source |
Imperial College London |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.