search
Back to results

Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology (5GSUCCEEDS)

Primary Purpose

Colorectal Cancer, Colon Capsule Endoscopy

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Setting up home delivery of Colon capsule endoscopy
Sponsored by
National Health Service, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gohar jalayeri NiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participant

Arm Description

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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2022
Last Updated
June 13, 2023
Sponsor
National Health Service, United Kingdom
search

1. Study Identification

Unique Protocol Identification Number
NCT05914597
Brief Title
Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
Acronym
5GSUCCEEDS
Official Title
5G SUCCEEDS Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Service, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Capsule Endoscopy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Assessing the acceptance of remote colon capsule endoscopy
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant
Arm Type
Other
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Setting up home delivery of Colon capsule endoscopy
Intervention Description
Feasibility study of home delivery of CCE
Primary Outcome Measure Information:
Title
Feasibility of home delivery of CCE service
Description
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
Time Frame
12month
Secondary Outcome Measure Information:
Title
assessing the patient's acceptability of home delivery of CCE service
Description
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.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gohar J Nia, MD
Phone
07592348533
Email
doctornia@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Ramesh Arasaradnam, PHD
Email
r.arasaradnam@warwick.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gohar J Nia, MD
Organizational Affiliation
National Health System United Kingdom
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor Ramesh Arasaradnam, PHD
Organizational Affiliation
National Health System United Kingdom
Official's Role
Study Director
Facility Information:
Facility Name
Gohar jalayeri Nia
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gohar Jalayeri Nia, MD
Phone
07592348533
Email
gohar.jalayerinia1@uhcw.nhs.uk
First Name & Middle Initial & Last Name & Degree
Ramesh Arasaradnam, Professor
Email
ramesh.arasaradnam@uhcw.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are aiming to share IPD to other researchers such as protocol and CSR
IPD Sharing Time Frame
12 month

Learn more about this trial

Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology

We'll reach out to this number within 24 hrs