NCT03254498

Brief Summary

A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 14, 2017

Last Update Submit

August 17, 2017

Conditions

Colonic NeoplasmsAdenomas SerratedColo-rectal CancerColon Adenoma

Keywords

colonic adenomaserrated polypscaecal intubation timewithdrawal timepolyp miss rate

Outcome Measures

Primary Outcomes (1)

  • Adenoma miss rate

    Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E

    1 day

Secondary Outcomes (5)

  • Mean adenoma per procedure

    1 day

  • Endocuff or cap exchange

    1 day

  • Ceacal intubation and withdrawal time

    1 day

  • miss rate of advanced polyps

    1 day

  • Comfort score

    1 day

Other Outcomes (1)

  • comparison of surveillance intervals

    Once histology is available usually takes 10-14 days

Study Arms (2)

Endocuff assisted colonoscopy

ACTIVE COMPARATOR

Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.

Device: Endocuff

Cap assisted colonoscopy

PLACEBO COMPARATOR

Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.

Device: cap assisted colonoscopy (CAC)

Interventions

EndocuffDEVICE

It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination

Endocuff assisted colonoscopy
cap assisted colonoscopy (CAC)DEVICE

cap assisted colonoscopy (CAC)

Cap assisted colonoscopy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and over
  • Referral for surveillance, or diagnostic colonoscopy
  • Ability to give informed consent

You may not qualify if:

  • Absolute contraindications to colonoscopy
  • Established or suspicion of large bowel obstruction or pseudo-obstruction
  • Known colon cancer or polyposis syndromes
  • Known colonic strictures
  • Known severe diverticular segment (that is likely to impede colonoscope passage)
  • Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Patients lacking capacity to give informed consent
  • Pregnancy
  • Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthWest London Hospitals - NOrthwick park hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Publications (1)

  • Rameshshanker R, Tsiamoulos Z, Wilson A, Rajendran A, Bassett P, Tekkis P, Saunders BP. Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT). Gastrointest Endosc. 2020 Apr;91(4):894-904.e1. doi: 10.1016/j.gie.2019.11.046. Epub 2019 Dec 10.

    PMID: 31836474DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Brian P Saunders, MD

    St Mark's Hospital, Northwest London Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 18, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)