LumenEye During CovID-19 (LuCID Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Patient Experience of LumenEye Examination
研究概览
简要总结
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.
详细描述
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.
All patients enrolled into the study will be asked to have a 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:
- The rectosigmoid junction
- Each rectal haustral fold
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and over
- •Patients with any of the following:
- •Positive Faecal occult blood test / Faecal immunochemical test (FIT)
- •Positive faecal calprotectin.
- •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
排除标准
- •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
结局指标
主要结局
Patient Experience of LumenEye Examination
时间窗: On the day of examination
Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale
Clinician Experience of LumenEye Examination
时间窗: On the day of examination
Assessing the the positive response rate by examining clinicians to their overall experience and certainty of diagnosis for each examination
次要结局
- Diagnostic Accuracy of the LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation(Diagnostic accuracy of the LumenEye examination to be compared with subsequent investigations completed by the time of analysis (2-9 months after study examination).)