Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747665
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2021-01-27
Brief Title:
Experiences and Perceptions of Colonoscopy and New Technologies
Sponsor:
The Leeds Teaching Hospitals NHS Trust
Organization:
The Leeds Teaching Hospitals NHS Trust
Study Overview
Official Title:
Patient and Endoscopists Experiences and Perceptions of Colonoscopy and New Technologies in Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bowel cancer is the 3rd most common cancer in males and females Most bowel cancers develop from precancerous polyps in the bowel Colonoscopy can detect and remove these polyps thereby reducing the risk of developing bowel cancer However colonoscopy is an invasive procedure with inherent risk and can be both uncomfortable and embarrassing to undergo The risks and numerous other barriers often mean colonoscopy and cancer preventing polyp removal is not performed
The investigators aim to start the first in-human feasibility clinical investigation of a robotic magnetic colonoscope in 2021 The new device aims to reduce the discomfort and risk associated with colonoscopy As part of the patient and end user involvement aspect of the project the investigators aim to perform a mixed methodology inductive type research project exploring experiences of colonoscopy for patient and endoscopists
The study will follow an exploratory mixed methodology format with two parallel work-streams for patients and endoscopists Each work-stream will consisting of a focus groups 1-2 for each patients and endoscopists followed by 20 endoscopist and 30 patient in-depth interviews then an online questionnaire Each stage will be thematically analysed to form the semi-structured questions for the next stage The target population will be endoscopists who perform colonoscopy and people who have undergone or refused to undergo a colonoscopy Focus groups will be performed in groups of 6-10 participants and both interview and focus groups will be performed via videoteleconferencing
The investigators aim to start the first in-human feasibility clinical investigation of a robotic magnetic colonoscope in 2021 The new device aims to reduce the discomfort and risk associated with colonoscopy As part of the patient and end user involvement aspect of the project the investigators aim to perform a mixed methodology inductive type research project exploring experiences of colonoscopy for patient and endoscopists
The study will follow an exploratory mixed methodology format with two parallel work-streams for patients and endoscopists Each work-stream will consisting of a focus groups 1-2 for each patients and endoscopists followed by 20 endoscopist and 30 patient in-depth interviews then an online questionnaire Each stage will be thematically analysed to form the semi-structured questions for the next stage The target population will be endoscopists who perform colonoscopy and people who have undergone or refused to undergo a colonoscopy Focus groups will be performed in groups of 6-10 participants and both interview and focus groups will be performed via videoteleconferencing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None