The ADENOMA study - a study of a device to improve detection of polyps during colonoscopy

ISRCTN	ISRCTN11821044
DOI	https://doi.org/10.1186/ISRCTN11821044
ClinicalTrials.gov number	NCT02552017
Secondary identifying numbers	v 5.0, 07.08.2014

Submission date: 27/08/2014
Registration date: 06/10/2014
Last edited: 21/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-device-that-may-help-to-find-polyps-in-the-bowel-the-adenoma-study

Contact information

Prof Colin Rees
Scientific

South Tyneside Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom

Study information

Study design	Multicentre prospective randomised controlled interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities
Study acronym	ADENOMA
Study objectives	It is predicted that using the Endocuff Vision will improve the adenoma detection rate. Primary objective: 1. To detect a difference in adenoma detection rate between Endocuff-Assisted Colonoscopy (EAC) and Standard Colonoscopy (SC) Secondary objectives: 1. To detect a difference in mean adenomas detected per procedure (MAP2) between EAC and SC 2. To establish the rate of cuff exchange (that is, how often the cuff has to be removed) 3. To demonstrate non-inferiority of caecal intubation rates and insertion time to caecum between EAC and SC 4. To demonstrate non-inferiority in complete withdrawal time in procedures where no polyps are detected between EAC and SC 5. To demonstrate non-inferiority of patient satisfaction with EAC compared to SC 6. To identify any difference in future colonoscopic workload produced by increased ADR in terms of number of potential follow-up procedures based on BSG adenoma surveillance guidelines between the EAC and SC groups These outcomes will be analysed on an intention-to-treat basis.
Ethics approval(s)	NRES Committee North East - York. REC, ref. 14/NE/1111 - review date 12/09/2014
Health condition(s) or problem(s) studied	Conditions requiring colonoscopy assessment, colonic adenomas
Intervention	Two study arms: 1. Control arm - routine colonoscopy performed in standard fashion with no Endocuff Vision attached to scope 2. Intervention arm - colonoscopy performed with Endocuff Vision device attached to end of colonoscope Intervention will be for the duration of the colonoscopy only. Participants will also complete a patient experience questionnaire immediately after, and within a week after, the procedure. Histology results of any polyps detected will be reviewed by the research team, and 30-day adverse events recorded.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	Adenoma detection rate (ADR)
Secondary outcome measures	1. Mean adenomas detected per procedure (MAP) 2. The rate of cuff exchange (that is, how often the cuff has to be removed) 3. Caecal intubation rates and insertion time to terminal ileum (to demonstrate non-inferiority) 4. Complete withdrawal time in procedures where no polyps are detected (to demonstrate non-inferiority) 5. Patient satisfaction 6. To identify any difference in future colonoscopic workload produced by increased adenoma detection rate in terms of number of potential follow-up procedures based on BSG adenoma surveillance guidelines between the EAC and SC groups
Overall study start date	06/10/2014
Completion date	30/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1772 participants (886 in each arm of the study)
Key inclusion criteria	1. Age 18 years and over 2. Referral for screening, surveillance or diagnostic colonoscopy 3. Ability to give informed consent
Key exclusion criteria	1. Absolute contraindications to colonoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that would be likely to prevent passage of the colonoscope) 6. Patients with acute colitis (ulcerative, Crohns and diverticulitis) 7. Patients lacking capacity to give informed consent 8. Pregnancy
Date of first enrolment	06/10/2014
Date of final enrolment	30/06/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Tyneside Hospital

South Shields
NE34 0PL
United Kingdom

Sponsor information

South Tyneside NHS Foundation Trust (UK)
Hospital/treatment centre

South Tyneside Hospital
Harton Lane
South Shields
NE34 0PL
England
United Kingdom

Phone	+44 (0)191 404 1000
Email	claire.livingstone@stft.nhs.uk
"ROR"	https://ror.org/044j2cm68

Funders

Funder type

Industry

ARC Medical Design Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/02/2019		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

21/05/2021: Cancer Research UK lay results summary link added to Results (plain English).
21/01/2019: The NCT code has been added.
31/01/2018: Publication reference added.