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Trial Title:
Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
NCT ID:
NCT05914597
Condition:
Colorectal Cancer
Colon Capsule Endoscopy
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Assessing the acceptance of remote colon capsule endoscopy
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Setting up home delivery of Colon capsule endoscopy
Description:
Feasibility study of home delivery of CCE
Arm group label:
Participant
Summary:
Patients without alarming symptoms are at low risk of bowel cancer . However, in majority
of those patients colonoscopy (gold standard) is needed to diagnose colorectal cancer or
other non-neoplastic conditions such as Inflammatory bowel disease . Evaluation of
patients with lower gastrointestinal symptoms ( low-intermediate risk group) represent
significant pressure for colonoscopy services . At the end of August 2019 there were a
total 44,388 patients still waiting for colonoscopy.
Covid 19 pandemic has placed significant pressure on healthcare systems since March
2020.The aerosol generating potential of endoscopy has led to multiple Gastroenterology
and Endoscopy societies suggesting immediate cessation of all but emergency colonoscopy
during the peak phase of the pandemic which put colonoscopy capacity even more under
pressure Data from the National Endoscopy Database indicate that total endoscopic
activity fell rapidly to 5% of normal levels during the peak phase of the COVID-19
epidemic in the UK (from approximately 35 000 reported procedures per week to 1700, for
the week ending 13 April .
In order to reduce potential diagnostic delays as a result of COVID pandemic , the role
of colon capsule endoscopy (CCE) as a non invasive diagnostic test is being increasingly
recognise, which allows for a pain-free colonic assessment by eliminating the need for
instrument insertion, gas insufflation or sedation .
The aim of the 5G SUCCEEDS study is to trial feasibility of home delivery of Colon
Capsule Endoscopy service with the help of 5 G technology. Currently patients need to
attend hospital to access this service.
Detailed description:
According to the European Society of Gastrointestinal Endoscopy (ESGE), CCE can be used
in average-risk patients for CRC screening and as an adjunctive test in patients with a
prior incomplete Colonoscopy, or in whom the latter is contraindicated or refused CCE.
Therefore, it is a potentially beneficial method of investigating patients by reducing
the pressure on the restricted endoscopy services in the post-COVID era. In line with
that, the NHS England is implementing a pilot project of CCE in patients referred on the
two weeks wait pathway. The purpose of this study is to provide an alternative diagnostic
test, while colonoscopy investigations are delayed due to the COVID Pandemic. This
initially is undertaken in those at low risk of colorectal cancer. Low risk patients will
have low levels of blood in the stool measured by FIT. Those at high risk will proceed
straight to colonoscopy .
At present in order to perform the CCE procedure it still requires patients to attend
hospital, usually carried out by one healthcare professional. It involves ļ¬tting a
receiver belt to the patient and oral administration of the disposable capsule. Therefore
we propose a different mode of delivery to avoid hospital visit in order to mitigate
COVID risk, in line with integrated care system of delivery away from hospital.
We believe implementing digitally-enabled care will significantly reduce travel and
journeys to hospital and will contribute to care closer to home. Setting up CCE home
delivery system can facilitate many sustainability benefits including reduction or
repurposing of estate footprint, reduced local air pollution, increased patient wellbeing
/choice and time savings for the workforce . By implying new digital technology such as
5G we will be able to deliver the CCE service more effectively and productively, with
patients at the centre which is in line with NHS X digital strategy .
The aim of this study is to trial feasibility of home delivery of Colon Capsule Endoscopy
service with the help of 5 G technology. Currently patients need to attend hospital to
access this service.
The term "5G" refers to the fifth generation of wireless transmission technology,
expected to have a significant influence in many aspects of contemporary society,
including healthcare. Based on 5G super bandwidth per unit area, connectivity, coverage
(up to 100%), and capacity to connect devices per unit will lead to an ecosystem in which
an "intelligence network" can serve real-time interactivity for massive medical equipment
and patients' wearable devices, with cloud computing-based trade-offs between speed,
latency, coverage, availability. COVID-19 has caused widespread healthcare impact
.Countries and healthcare systems around the world have been forced to rapidly adapt to
tele-health and digital innovations to mitigate the impact of the risk of virus
transmission to what is widely regarded as the "new normal". With 5G technology, which
has lower latency and higher capacity, healthcare systems can provide the care their
patients need and expect remotely .
Working with specialist connectivity partners, the CCE smartbox has been developed by
CorporateHealth International, an Inverness-based capsule endoscopy service provider. A
device supported by 5 G can be used independently in patient's homes. The Smartbox will
be utilised to make telecommunication with the patient robust and safe, reducing the risk
of failed procedure attempts. Faster and reliable 5G internet will enable the use of a
'virtual assistant' that can provide answers and guidance to the patient while clinicians
can track and monitor the location of the equipment throughout the process. It is
anticipated that the adoption of 5G to enable home testing will reduce waiting times and
speed up the process of identifying irregularities and any subsequent treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients who have been selected by overseeing clinician meeting NHS England criteria
to undergo colon capsule endoscopy as part of their standard of care
- Age between 18-55
Exclusion Criteria:
- Patients unable or unwilling to provide consent to take part in the study
- Patient is pregnant
- Standard CCE exclusion criteria
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gohar jalayeri Nia
Address:
City:
Coventry
Zip:
CV2 2DX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Gohar Jalayeri Nia, MD
Phone:
07592348533
Email:
gohar.jalayerinia1@uhcw.nhs.uk
Contact backup:
Last name:
Ramesh Arasaradnam, Professor
Email:
ramesh.arasaradnam@uhcw.nhs.uk
Start date:
December 12, 2022
Completion date:
August 30, 2023
Lead sponsor:
Agency:
National Health Service, United Kingdom
Agency class:
Other
Source:
National Health Service, United Kingdom
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914597
