Condition category
Digestive System
Date applied
27/08/2014
Date assigned
06/10/2014
Last edited
18/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Colin Rees

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v 5.0, 07.08.2014

Study information

Scientific title

Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities

Acronym

ADENOMA

Study hypothesis

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

NRES Committee North East - York. REC, ref. 14/NE/1111 - review date 12/09/2014

Study design

Multicentre prospective randomised controlled interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

06/10/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years and over
2. Referral for screening, surveillance or diagnostic colonoscopy
3. Ability to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1772 participants (886 in each arm of the study)

Participant 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, Crohn’s and diverticulitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy

Recruitment start date

06/10/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tyneside Hospital
South Shields
NE34 0PL
United Kingdom

Sponsor information

Organisation

South Tyneside NHS Foundation Trust (UK)

Sponsor details

South Tyneside Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
+44 (0) 191 404 1000
claire.livingstone@stft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

ARC Medical Design Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes