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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04747665
Other study ID # IRAS 281674
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source The Leeds Teaching Hospitals NHS Trust
Contact Conchubhair Winters, MBChB
Phone 07841043502
Email conchubhair.winters@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 video/teleconferencing.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: One of: - undergone a colonoscopy - offered a colonoscopy but declined - perform or training to perform colonoscopy Exclusion Criteria: - Non-English speaking - Unable to comply with any study requirements - New or ongoing diagnosis of bowel cancer

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient and endoscopist reported experience
Exploration of patient and endoscopists experiences of colonoscopy.

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient participant reported experience of colonoscopy - focus group Descriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy. 1 year
Primary Patient participant reported experience of colonoscopy - interviews Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy. 1 year
Primary Patient participant reported barriers to colonoscopy - focus group Descriptive reporting on thematic analysis following a focus groups involving patients exploring the barriers to colonoscopy. 1 year
Primary Patient participant reported barriers to colonoscopy - interviews Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy. 1 year
Primary Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group Descriptive reporting on thematic analysis of a focus groups involving colonoscopists exploring what they feel to be important patient experience measures in colonoscopy. 1 year
Primary Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important patient experience measures in colonoscopy. 1 year
Primary Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group Descriptive reporting on thematic analysis of a focus group involving colonoscopists exploring what they feel to be important barriers to colonoscopy for patients. 1 year
Primary Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important barriers to colonoscopy for patients. 1 year
Primary PREMs patient participant questionnaire Level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions. 1 year
Primary PREMs colonoscopist participant questionnaire Perceived level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions. 1 year
Secondary Patient participants thoughts and feelings about robotic colonoscopy - focus group Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope. 1 year
Secondary Patient participants thoughts and feelings about robotic colonoscopy - interview Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope. 1 year
Secondary Patient participants thoughts and feelings about artificial intelligence - focus group Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a artificial intelligence in endoscopy 1 year
Secondary Patient participants thoughts and feelings about artificial intelligence - interviews Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a artificial intelligence in endoscopy 1 year
Secondary Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope. 1 year
Secondary Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope. 1 year
Secondary Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy. 1 year
Secondary Colonoscopist participants thoughts and feelings about artificial intelligence - interviews Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy. 1 year
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