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临床试验/NCT05914597
NCT05914597招募中不适用

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

National Health Service, United Kingdom1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Feasibility of home delivery of CCE service

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Patients unable or unwilling to provide consent to take part in the study
  • •Patient is pregnant
  • •Standard CCE exclusion criteria

研究组 & 干预措施

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 .

干预措施: Setting up home delivery of Colon capsule endoscopy (Other)

结局指标

主要结局

Feasibility of home delivery of CCE service

时间窗: 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

次要结局

  • assessing the patient's acceptability of home delivery of CCE service(6 month)

研究者

发起方
National Health Service, United Kingdom
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr Gohar Jalayeri Nia

Dr Gohar Jalayeri Nia

National Health Service, United Kingdom

研究点 (1)

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