LumenEye During CovID-19 (LuCID Study)
Conditions: Bowel Cancer, Bowel Diseases, Inflammatory, Rectal Bleeding
Sponsor: Imperial College London

LuCID Study – Protocol V1.2.1 
 
 
1 
 
 
 
 
 
 
 
 
 
LumenEye during CovID-19 (LuCID study) 
 
Study Protocol 
 
IRAS project ID: 285758 
 
 
Version 1.2.1 
 
27/08/2020 
 
 
 
 
 
 
 
 
Main Sponsor: Imperial College London  
Funders: SurgEase Innovations Ltd 
Study Coordination Centre: Imperial College NHS trust 
NRES reference:  
 
 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

LuCID Study – Protocol V1.2.1 
 
 
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Study Management Group 
 
Chief Investigator:  
James Kinross 
Co-investigators:  
Bu Hayee, Fareed Iqbal, Henry Tilney, Nisha Patel, Nick Powel,  
Statistician:  
Study Management:   Department of Surgery and Cancer 
 
 
Study Coordination Centre  
 
Imperial College London 
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: James Kinross 
 
 
E-mail: j.kinross@imperial.ac.uk 
Address: 10th Floor, QEQM, London W2 1NY 
Web address www.surgease.com 
  
Tel:07989344238  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Queries 
 
Clinical queries should be directed to James Kinross who will direct the query to the 
appropriate person 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
Funder 
 
SurgEase Innovations Ltd 
 
 
 
 
 

LuCID Study – Protocol V1.2.1 
 
 
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This protocol describes the LUCID study and provides information about procedures for 
entering participants.  Every care was taken in its drafting, but corrections or amendments may be 
necessary. These will be circulated to investigators in the study.  Problems relating to this study 
should be referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance Framework 
for Health and Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data 
Protection Act and other regulatory requirements as appropriate. 
 
Contents 
 
1 
Introduction .................................................................................................................... 8 
1.1 
Background............................................................................................................. 8 
1.1.1 
Colitis assessment ........................................................................................... 8 
1.1.2 
Bowel Cancer Screening and 2-week wait referrals ......................................... 9 
1.1.3 
Covid19 and endoscopy services ..................................................................... 9 
1.1.4 
LumenEye and CHiP ....................................................................................... 9 
1.2 
Rationale for current study .................................................................................... 10 
1.3 
Study Objectives ................................................................................................... 10 
2 
Study Design ............................................................................................................... 11 
2.1 
Recruitment .......................................................................................................... 11 
2.2 
Quality assurance and training .............................................................................. 12 
2.3 
Analysis ................................................................................................................ 12 
2.4 
Study Outcome Measures ..................................................................................... 13 
3 
Participant Entry........................................................................................................... 13 
3.1 
Pre-registration evaluations .................................................................................. 13 
3.2 
Inclusion Criteria ................................................................................................... 13 
3.3 
Exclusion Criteria .................................................................................................. 13 
3.4 
Withdrawal Criteria ................................................................................................ 14 
4 
Adverse Events ............................................................................................................ 14 
4.1 
Definitions ............................................................................................................. 14 
4.2 
Reporting Procedures ........................................................................................... 14 
4.2.1 
Non serious AEs ............................................................................................ 14 
4.2.2 
Serious AEs ................................................................................................... 14 
4.2.3 
Contact details for reporting SAEs ................................................................. 15 
5 
Assessment and Follow-up .......................................................................................... 15 
6 
Statistics and data analysis .......................................................................................... 15 
7 
Regulatory issues ........................................................................................................ 15 
7.1 
Ethics approval ..................................................................................................... 15 
7.2 
Consent and Confidentiality .................................................................................. 15 
7.3 
Data Storage and Retention .................................................................................. 16 
7.4 
Indemnity .............................................................................................................. 16 

LuCID Study – Protocol V1.2.1 
 
 
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7.5 
Sponsor ................................................................................................................ 16 
7.6 
Funding ................................................................................................................. 16 
7.7 
Audits.................................................................................................................... 16 
8 
Study Management ...................................................................................................... 16 
8.1 
Data Management Committee .............................................................................. 17 
9 
Publication Policy ......................................................................................................... 17 
10 
References ............................................................................................................... 19 
 
 
 
 
 

LuCID Study – Protocol V1.2.1 
 
 
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Study Summary 
 
 
 
 
 
TITLE 
LumenEye during CovID-19 (LuCID study) 
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: 
1. To assess the safety and acceptability of the LumenEye and CHiP system  
in primary and secondary care.  
2. To establish the clinical utility of the CHiP software system for performing 
remote telemedicine assessment of the rectum and colon.  
3. 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: 
1. To establish the clinical utility of the CHiP software system for performing 
remote telemedicine assessment of the rectum and colon.  
2. 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: 
i) 
rectal bleeding  
ii) 
established ulcerative colitis requiring assessment  
iii) 
Positive Faecal occult blood test / Faecal immunochemical test (FIT) 
or faecal calprotectin  
iv) 
any symptom that would warrant referral on the 2WW cancer 
referral pathway  
DURATION 
1 year 

LuCID Study – Protocol V1.2.1 
 
 
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Reference Diagrams 
 
 
Figure 1: The LumenEye is a CE Marked digital rectoscope    
 
 
 
 
Figure 2: The CHiP software system 

LuCID Study – Protocol V1.2.1 
 
 
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LuCID Study – Protocol V1.2.1 
 
 
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1 Introduction 
 
1.1 Background 
 
Rigid sigmoidoscopy (RS) is an established diagnostic procedure used by clinicians 
worldwide. In the modern context, RS is typically used to make a luminal assessment of the 
distal gastrointestinal tract; up to 25 centimetres from the anal verge. The typical instrument 
arrangement consists of four main components: a light source, a rigid tube, a light head 
(sealed viewing window and fibre optic light connection) and an insufflation bellows. A 
standard RS also permits the introduction of forceps, needles, and other instruments. 
Increasingly, RS sets are disposable single use systems, self-lubricating and scope lengths 
average between 20-25 centimetres with diameters of up to 2 centimetres. The tube is inserted 
via the anus and has been reported to reach the distal sigmoid flexure in some series.(1) 
Anorectal symptoms are a common complaint in both primary and secondary care. 
These include haematochezia, pruritus ani, proctalgia, anorectal swellings, discharge, change 
in bowel habit and incontinence. Rigid sigmoidoscopy is therefore typically performed in 
outpatient clinics in an unprepared bowel by healthcare professionals; particularly: 
gastroenterologists, general surgeons, primary care physicians and nurses.(2) RS provides 
clinical value through the early detection of polyps and malignant lesions within the rectum; 
but it also contributes to therapy and improved patient experience through the detection and 
management of benign disease.(3)  It can be easily deployed for longitudinal assessment of 
pathology and treatment response and ultimately if used correctly it avoids the requirement 
for repeat visits for more costly investigations such as  flexible sigmoidoscopy. But despite the 
common use and simplicity of RS as a diagnostic tool, its use is declining as it is replaced by 
flexible scopes despite is broad range of applications for patient benefit.  
We have systematically reviewed this literature as part of this ethical approval process. 
Of 2,086 citations reviewed, 35 were eligible for analysis which included 27,369 episodes of 
rigid sigmoidoscopy. RS was used most commonly in secondary care in the assessment of 
symptomatic patients. It was also used in the screening of asymptomatic patients and in the 
surveillance and monitoring of patients with anorectal disease. The mean distance reached 
ranged from 12 to 22.4cm (n=5552). The average time taken was 4 minutes 30 seconds. 
Adverse events were reported in 11 articles (n= 19,632), the pooled complication rate was 
0.01%. Of the three studies to discuss the risk of cross-contamination (n=145 two confirmed 
a theoretical risk due to bacterial harbouring in reusable components of the device. No patient 
preparation was used in 8 studies, enemas/suppositories were used in 15 studies and 
preparation was not reported by 12 studies.  General anaesthetic and analgesia were used in 
children and in patients undergoing another procedure (e.g. laparoscopy, colonoscopy). This 
is therefore a safe and highly applicable technology.  
 
1.1.1 Colitis assessment 
 
Inflammatory bowel disease (IBD), comprising Crohn’s disease (CD) and ulcerative 
colitis (UC), is a condition in which the gastrointestinal immune system responds 
inappropriately. IBD is therefore often treated with immunosuppressing medications to control 
inflammation and prevent ‘flares’, a worsening of symptoms, which may be unpredictable. 
While it is known that 0.8% of people in the UK currently have IBD (approximately 524 000 
patients), only 44% have been to a clinic in the past 3 years. The greatest risks during Covid-
19 relate not only to the infection itself, but also the emergency reorganisation of hospital and 
general practice services to deal with the pandemic. This has resulted in significant changes 
to routine IBD services. A combined approach covering both primary and secondary care is 
therefore required to keep vulnerable patients with IBD out of hospital as much as possible.   
 

LuCID Study – Protocol V1.2.1 
 
 
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Current guidance from the BSG states: “Patients who may require hospitalisation will 
need to continue to be assessed in a timely manner. Consider the most appropriate location 
to do this that is away from COVID-19 assessment areas. Daily ‘flare clinics’ (virtual where 
possible) with limited numbers of patients who are at high risk of imminent hospitalisation 
should be considered. Where possible, limit visits to hospital and limit the patient journey 
around the hospital geographically.(4) 
 
1.1.2 Bowel Cancer Screening and 2-week wait referrals 
 
Approximately 1,240,000 new cases of colorectal cancer (CRC) were diagnosed 
globally in 2008, making it a lethal and highly prevalent disease. There are 16,000 deaths and 
41,000 new cases are diagnosed in the UK each year from bowel cancer, affecting 1 in 14 
men and 1 in 19 women. 20% of patients present as an emergency and over 50% will have 
advanced disease, and significantly worse outcome. The number of patients diagnosed with 
bowel cancer in the UK is set to increase and there is no feasible methodology for prevention.  
The disease carries a significant cost to the NHS of approximately £1.6 billion annually. A 
national bowel cancer screening program has thus been developed based on a screening 
faecal occult blood test.  Uptake of the screening programme ranges between 55 to 60% and 
2.5% of men and 1.5% of women have an abnormal test. 98% of patients have a colonoscopy 
as their first investigation. Colonoscopy remains the gold standard for CRC screening despite 
its associated morbidity and economic cost. Cancer (n=1772) and higher risk adenomas 
(n=6543) were found in 11.6% and 43% of men and 7.8% and 29% of women investigated, 
respectively. 71% of cancers were ‘early’ (10% polyp cancer, 32% Dukes A, 30% Dukes B) 
and 77% were left-sided (29% rectal, 45% sigmoid) with only 14% being right-sided compared 
with expected figures of 67% and 24% for left and right side from UK cancer registration.(4) 
However, several studies have demonstrated the efficacy of flexible sigmoidoscopy as a first 
line screening test, and this is now employed in the UK. The Flexiscope trial reduced the 
incidence of colorectal cancer by 23% and mortality by 31%. The Incidence of distal colorectal 
cancer (rectum and sigmoid colon) was reduced by 50%.(5) Therefore, there is a significant 
need for biomarkers that can support decision making in the selection of the correct definitive 
follow up investigation(6) and there is an urgent requirement for an office based endoscopy 
service that can provide the ability to detect rectal cancers during the covid-19 pandemic.   
 
1.1.3 Covid19 and endoscopy services 
 
Despite staff infection rates from endoscopy remaining low during the Covid-19 
pandemic (7), staff safety from aerosol transmission remains concern.(8) All but emergency 
and essential endoscopy has been stopped in response to Covid-19 in the UK, so service 
provision for the symptomatic and screening populations can be reviewed and 
reorganised.  Data from the National Endoscopy Database shows that the total numbers of 
endoscopic procedures fell in just 2 weeks in March from 33 000 to 7000 and has fallen further 
since. When endoscopy services resume, capacity will be significantly reduced due to the 
additional novel covid-19 cleaning requirements and the significant waiting times that are likely 
to be present.  
 
1.1.4 LumenEye and CHiP 
 
The intervention: The LumenEye X1 (SurgEase Innovations Ltd, UK) is a CE Marked 
novel point of care rigid digital endoscope which provides High-Definition views of the rectum 
up to 20cm from the anal verge. It permits endoscopic biopsy under view (figure 1) and 
maintains pneumorectum sufficiently with as little as 100ml of air. Air delivery is in a closed 
system thereby significantly reducing aerosol transmission relative to formal endoscopy. This 
feature is particularly attractive in the current Covid-19 pandemic. A removable disposable 
manifold and a chemical clean with Tristel™ Trio is the only requirement for reprocessing 

LuCID Study – Protocol V1.2.1 
 
 
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which is more cost-effective than automated washing & sterilisation. All images and videos 
are displayed on a HD screen, supplied alongside the scope, which can be captured and 
stored securely on the cloud platform (called CHiP, Figure 2) which allows retrospective review 
of images and data taken during rectoscopy from any device. The technology permits high 
quality endoscopy at the bedside and outside of traditional tiers of care which is particularly 
attractive during the current Corona pandemic. An additional feature of CHiP includes 
telemedicine functionality with live video sharing of the camera feed; a proctor can be invited 
over WIFI into a session who can then view the live feed from the scope and offer advice and 
guidance. The technology can offer cost-effective, immediate tumour visualisation, critical 
measurement, opportunity for biopsy and virtual diagnostic support.  
 
 
1.2 Rationale for current study 
 
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. 
 
 
1.3 Study Objectives 
 
Primary objective: 
 
To assess both safety and patient and clinical acceptance of the LumenEye 
device with specialist consultation over the CHiP platform. 
 
Secondary objectives: 
 
1. To establish the clinical utility of the CHiP software system for performing 
remote telemedicine assessment of the rectum and colon.  
2. 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. 
 
 

LuCID Study – Protocol V1.2.1 
 
 
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2 Study Design 
 
We propose a multi-centre prospective observational pilot study of the LumenEye and 
CHiP system. The experimental design is pragmatic and designed to permit the recruitment 
of patients in a timely fashion necessary for a prospective, confirmatory analysis during the 
Covid-19 pandemic. The study outline is provided in figure 3.  
 
 
 
 
Figure 3. Overview of study protocol 
 
 
2.1 Recruitment 
 
Patients will be identified for recruitment via two routes: 
 
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 
 
All patients will be provided with written information about the study and an online website will 
be created to provide this information. The study aims to recruit 100 patients into the pilot 
study. 
 
 

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2.2 Quality assurance and training 
 
All clinicians will be provided with an onboarding protocol and a LumenEye SOP for 
standardised use, which include recommendations for use during the Covid-19 pandemic will 
be created. 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.  Additional primary sites will be 
located at: 
 
King’s College Hospital NHS Foundation Trust- Dr. Bu Hayee  
NHS Frimley Health Foundation Trust – Dr. Henry Tilney  
 
 
All patients enrolled into the study will be asked to have either an enema or 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.  
 
 
2.3 Analysis 
 
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.  
Local users of the LumenEye system will undergo nasal swab assessments every 4 
weeks for a covid-19 PCR test to ensure staff safety is maintained during the study. If a swab 
tests positive, the physician will be asked to follow standard PHE advice on isolation, contact 
tracing and further treatment.  
All LumenEye devices will undergo at least one random post-cleaning swab test for 
Covid-19 to confirm the Tristel Trio cleaning system sufficiently eradicates SARS-COv-2 from 
the LumenEye. (An analysis of this has been performed outside of the study which confirms 
the efficacy of the Tristel Trio system against SARS-COV-2).  
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.  
For flare patients, both clinicians will be asked to report Mayo flare scores based on observed 

LuCID Study – Protocol V1.2.1 
 
 
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data. For adenomas, clinicians will be asked to report anatomical location, morphology, and 
Paris endoscopy assessment scores. All data pertaining to follow up colonoscopy or flexible 
sigmoidoscopy will be used as a comparator group for a diagnostic sensitivity / specificity 
analysis.  
 
 
2.4 Study Outcome Measures 
 
Primary outcome: 
 
Both safety and patient and clinical acceptance of the LumenEye device with 
specialist consultation over the CHiP platform. 
 
Secondary outcomes: 
 
1. To establish the clinical utility of the CHiP software system for performing 
remote telemedicine assessment of the rectum and colon.  
2. 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 
 
3 Participant Entry  
 
3.1 Pre-registration evaluations  
 
All IBD patients requiring urgent flare assessment, patients presenting to their GP with 
anorectal symptoms, rectal bleeding, change of bowel habit or with a diagnosis that warrants 
an endoscopy,  
 
3.2 Inclusion Criteria 
 
• 
Patients aged 18 and over 
• 
Patients with any of the following: 
o Positive Faecal occult blood test / Faecal immunochemical test (FIT)  
o Positive faecal calprotectin.  
o 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 
 
3.3 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  
 

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3.4 Withdrawal Criteria 
 
Consent will be withdrawn at the patient’s request. In the event that consent is removed, 
the images will be removed from the analysis.   
 
4 Adverse Events 
 
 
4.1 Definitions   
 
Adverse Event (AE):  
Any untoward medical occurrence in a patient or clinical study subject.  This may 
include the diagnosis of Covid-19 that is found to have been transmitted during the procedure 
 
Serious Adverse Event (SAE): 
Any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
 
4.2 Reporting Procedures 
 
All adverse events should be reported.  Depending on the nature of the event the 
reporting procedures below should be followed.  Any questions concerning adverse event 
reporting should be directed to the Chief Investigator in the first instance.   
 
4.2.1 Non serious AEs 
 
All such events, whether expected or not, will be recorded.   
 
4.2.2 Serious AEs 
 
Medical judgement will be exercised in deciding whether an adverse event is serious 
in other situations. Important adverse events that are not immediately life-threatening, or do 
not result in death or hospitalisation but may jeopardise a subject or may require intervention 
to prevent an adverse outcome should also be considered serious.  
 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse and death due to complication from subsequent investigations such as 
colonoscopy and hospitalisations for elective treatment of a pre-existing condition do not need 
reporting as SAEs. 
 
All SAEs should be reported to the Chief Investigator or Ruth Nicholson, where in the 
opinion of the Chief Investigator, the event was: 
 
‘related’, i.e. resulted from the administration of any of the research procedures; and 
‘unexpected’, i.e. an event that is not listed in the protocol as an expected occurrence 

LuCID Study – Protocol V1.2.1 
 
 
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Reports of related and unexpected SAEs should be submitted within 15 days of the 
Chief Investigator becoming aware of the event, using the NRES SAE form for non-IMP 
studies.  The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
4.2.3 Contact details for reporting SAEs 
 
Email:   
 
 
 
j.kinross@imperial.ac.uk  
Please send SAE forms to:  
Mr James Kinross, Department of Surgery and Cancer, 
10th Floor QEQM Building, St Mary’s Hospital, Praed 
Street, London, W2 1NY 
 
 
5 Assessment and Follow-up 
 
We will record clinical outcome data in patients with a new diagnosis of IBD or colon 
cancer, and we will record if they underwent medical therapy, surgery or endoscopic therapy. 
The aim is to determine if the LumenEye improves the time to diagnosis and treatment, and 
ultimately outcome. The study will end when the 100th patient has been assessed and 
undergone any further investigation warranted by their presentation. Any incidental findings 
will be noted on the case report form and investigated as per the usual clinical pathways. 
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
6 Statistics and data analysis 
 
 
This is a feasibility study. The aim is to establish whether the device is acceptable and to 
establish the initial diagnostic performance of this device. This data will be used to form the 
basis of a power calculation for future studies. All data will be analysed using SPSS v. 20 and 
will be analysed using standard univariate statistical models.  
 
 
7 Regulatory issues 
 
7.1 Ethics approval 
 
The Study Management Committee will obtain all relevant approvals from the Health 
Regulatory Authority (HRA), NHS Research Ethics Committee (NHS REC) and local 
organisations as required. The study will also receive confirmation of capacity and capability 
from each participating organisation. The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 18th 
World Medical Assembly, Helsinki 1964 and later revisions. 
  
 
7.2 Consent and Confidentiality 
 

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Individual informed consent for the capture, storage and analysis of LumenEye data and 
inclusion in the digital CHiP platform will be obtained from all participants. It will be the 
responsibility of local collaborators to obtain written informed consent from each participant 
after adequate explanation of the project, potential hazards and process for data capture and 
storage. The original copy of the signed and dated informed consent must be retained at the 
participating organisation and is subject to inspection by representatives of the Sponsor, or 
representatives from Regulatory Authorities. The standardised patient information sheet and 
consent form is included in this protocol. 
 
7.3 Data Storage and Retention 
 
All data will be stored for a minimum of 10 years (or according to changes in regulatory 
requirements). Data generated by this work will be processed in accordance with the Data 
Protection Act 1998. Retention and analysis will be conducted with regard to all local policies 
relating to the collection, holding and disclosure of data relating to individuals. The Principal 
and Co-applicants will act as custodians of the data and be responsible for its security. The PI 
will ensure the continued storage of all relevant data and documentation, even if they leave 
the clinic/practice or retire before the end of the required storage period. Delegation will be 
documented in writing.  
 
7.4 Indemnity 
 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study/ Imperial College Healthcare NHS Trust holds standard NHS 
Hospital Indemnity and insurance cover with NHS Litigation Authority for NHS Trusts in 
England, which apply to this study (delete as applicable) 
 
7.5 Sponsor 
 
Imperial College London will act as the main Sponsor for this study.  Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
7.6 Funding 
 
SurgEase Innovations will provide some funding towards the project and supply all 
diagnostic equipment and CHiP software for free.  
 
7.7 Audits  
 
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition).  
 
 
8 Study Management 
 
The day-to-day management of the study will be coordinated through the Study 
Management Committee (SMC) which will also function as the Scientific Advisory Board. The 
SMC will be convened including the Chief Investigator, co-investigators, and key collaborators. 
The committee will be responsible for day-to-day conduct of the trial and operational issues. 
  

LuCID Study – Protocol V1.2.1 
 
 
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Quality Control will be performed according to Imperial College London internal 
procedures. The study may be audited by a Quality Assurance representative of the Joint 
Research Compliance Office (JRCO) at Imperial College London. All necessary data and 
documents will be made available for inspection. The study may be subject to inspection and 
audit by regulatory bodies to ensure adherence to GCP and the NHS Research Governance 
Framework for Health and Social Care. 
 
8.1 Data Management Committee 
 
The SMC will form a Data Management Committee (DMC) that will be responsible for 
oversight and assurance of all data capture, storage, and analysis.  
 
 
9 Publication Policy 
 
The COVID pandemic has created a new paradigm for the conduct and dissemination of 
research. We will provide dynamic, interactive and real-time learning and dissemination of 
knowledge through a dedicated website. We will also employ non-traditional routes, such as 
social media platforms (e.g. Twitter, Facebook, LinkedIn), in order to ensure that there is rapid 
dissemination of the pertinent study findings. In addition to leveraging online dissemination 
strategies, we will also target the following groups in a more specific fashion: 
 
Policymakers: 
 
At regular intervals throughout the project, and upon completion, we will produce an 
executive summary of our findings, which is to be distributed to relevant policy makers (e.g. 
NHS Digital) so that the relevant results may be rapidly disseminated globally through official 
and well-respected sources. 
 
 
Clinicians and Health Managers: 
 
The main findings will be submitted for publication in peer-reviewed scientific journals 
and presented in national and international conferences. We will provide updated information 
concerning the publication of study results to all stakeholders. The study results will also be 
presented to healthcare commissioners and policy makers at appropriate meetings and in 
publications. 
  
 
Patients and the Public: 
 
We will produce a short, easy to understand summary of our research findings that will 
be available from our website or that can be sent to interested stakeholders. 
  
 
Academics: 
 
We will make our intervention methodology and results available through presentations, 
workshops, conferences, the website, working papers and journal articles. We will provide an 
interactive framework on a web-based platform to facilitate the adoption of our model and 
methodology in clinical practice. We will seek to publish and present our results in high impact 
peer-reviewed journals and at relevant international conferences. 

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