Colorectal Cancer5GSUCCEEDSNCT05914597
Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
A study testing Setting up home delivery of Colon capsule endoscopy in people with Colorectal Cancer and Colon Capsule Endoscopy, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Colorectal Cancer, Colon Capsule Endoscopy
- What is being tested?
- Setting up home delivery of Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients unable or unwilling to provide consent to take part in the study
- Patient is pregnant
- Standard CCE exclusion criteria
Trial locations and contacts
1 site in 1 country.
Professor Ramesh Arasaradnam, PHD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Gohar jalayeri Nia
Coventry, West Midlands, CV2 2DX
Gohar Jalayeri Nia, MD, 07592348533, gohar.jalayerinia1@uhcw.nhs.uk
Ramesh Arasaradnam, Professor, ramesh.arasaradnam@uhcw.nhs.uk
About this study
Official title: 5G SUCCEEDS Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
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 .
Read more
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.
Read the 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 fitting 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.
- Conditions
- Colorectal Cancer, Colon Capsule Endoscopy
- Being tested
- Setting up home delivery of Colon capsule endoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setting up home delivery of Colon capsule endoscopyOther
Feasibility study of home delivery of CCE
| Study group | Role | What they receive |
|---|---|---|
| Participant | Other | Patients with lower gastrointestinal symptoms who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care and are 18 or over . Receives: Other: Setting up home delivery of Colon capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of home delivery of CCE service
To assess the feasibility of Colon Capsule Endoscopy home delivery service, we followed a structured approach. We are aiming to deliver the whole CCE service at home by using a smartbox, 5G technology and telemedicine communication to conduct the study and troubleshoot any upcoming issues. The target population is based on the number of available smartboxes. Through a comprehensive process we obtained all the regulatory and ethical approval for conducting the study
Measured: 12month
Secondary outcomes (1)
assessing the patient's acceptability of home delivery of CCE service
One of the main aims of this study is to measure the patient' satisfaction. We design the questionnaire to capture the necessary information. We wanted to include factors such as quality of care, experience with using the capsule endoscopy equipment and smartbox at home, and overall experience. Format of the questionnaire is mainly structured with closed-ended questions (multiple-choice or Likert scale. When we are using a scale from 0 to 5, 0 represents extremely easy and 5 represents extremely difficult. Based on our identified domains, we develop specific questions that assess patient satisfaction within each domain, and we ensure that the questions are clear, concise, and unambiguous and we avoided leading or biased questions that may influence the responses.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start12 Dec 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assessing the acceptance of remote colon capsule endoscopy
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Gohar Jalayeri Nia, National Health Service, United Kingdom
- Investigators
- Gohar J Nia, MD, Principal investigator, National Health System United KingdomProfessor Ramesh Arasaradnam, PHD, Study director, National Health System United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914597
- Sponsor's protocol ID
- 311685
- Acronym
- 5GSUCCEEDS
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are aiming to share IPD to other researchers such as protocol and CSR
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5G SUCCEEDS Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
- ClinicalTrials.gov ID
- NCT05914597
- Acronym / sponsor ID
- 5GSUCCEEDS / 311685
- Conditions
- Colorectal Cancer, Colon Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fitting 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessing the acceptance of remote colon capsule endoscopy
| Arm | Type | Receives |
|---|---|---|
| Participant | Other | Other: Setting up home delivery of Colon capsule endoscopyPatients with lower gastrointestinal symptoms who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care and are 18 or over . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients unable or unwilling to provide consent to take part in the study
- Patient is pregnant
- Standard CCE exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Setting up home delivery of Colon capsule endoscopyFeasibility study of home delivery of CCE | Other | Participant |
Primary outcome
Feasibility of home delivery of CCE service
Time frame: 12month
To assess the feasibility of Colon Capsule Endoscopy home delivery service, we followed a structured approach. We are aiming to deliver the whole CCE service at home by using a smartbox, 5G technology and telemedicine communication to conduct the study and troubleshoot any upcoming issues. The target population is based on the number of available smartboxes. Through a comprehensive process we obtained all the regulatory and ethical approval for conducting the study
1 secondary outcome
assessing the patient's acceptability of home delivery of CCE service
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. We are aiming to share IPD to other researchers such as protocol and CSR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ramesh Arasaradnam, PHD contact
Gohar J Nia, MD principal investigator
National Health System United Kingdom
Professor Ramesh Arasaradnam, PHD study director
National Health System United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setting up home delivery of Colon capsule endoscopy in people with Colorectal Cancer and Colon Capsule Endoscopy, run by National Health Service, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gohar J Nia, MD (07592348533, doctornia@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of home delivery of CCE service (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.