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Detection in Tandem Endocuff Cap Trial (DETECT)

Primary Purpose

Colonic Neoplasms, Adenomas Serrated, Colo-rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endocuff
cap assisted colonoscopy (CAC)
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 is likely to impede colonoscope passage)
  6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  7. Patients lacking capacity to give informed consent
  8. Pregnancy
  9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure

Sites / Locations

  • NorthWest London Hospitals - NOrthwick park hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Endocuff assisted colonoscopy

Cap assisted colonoscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean adenoma per procedure
Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
Endocuff or cap exchange
Number of times Cap or Endocuff are removed to complete the procedure
Ceacal intubation and withdrawal time
Comparison of caecal intubation and withdrawal time
miss rate of advanced polyps
Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
Comfort score
Comparison of patient comfort score between CAC and EAC

Full Information

First Posted
August 14, 2017
Last Updated
August 17, 2017
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03254498
Brief Title
Detection in Tandem Endocuff Cap Trial
Acronym
DETECT
Official Title
Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Adenomas Serrated, Colo-rectal Cancer, Colon Adenoma
Keywords
colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
Masking
Investigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocuff assisted colonoscopy
Arm Type
Active Comparator
Arm Description
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
Arm Title
Cap assisted colonoscopy
Arm Type
Placebo Comparator
Arm Description
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
Intervention Type
Device
Intervention Name(s)
Endocuff
Intervention Description
It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
Intervention Type
Device
Intervention Name(s)
cap assisted colonoscopy (CAC)
Intervention Description
cap assisted colonoscopy (CAC)
Primary Outcome Measure Information:
Title
Adenoma miss rate
Description
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Mean adenoma per procedure
Description
Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
Time Frame
1 day
Title
Endocuff or cap exchange
Description
Number of times Cap or Endocuff are removed to complete the procedure
Time Frame
1 day
Title
Ceacal intubation and withdrawal time
Description
Comparison of caecal intubation and withdrawal time
Time Frame
1 day
Title
miss rate of advanced polyps
Description
Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
Time Frame
1 day
Title
Comfort score
Description
Comparison of patient comfort score between CAC and EAC
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
comparison of surveillance intervals
Description
To compare any surveillance interval difference between CAC and EAC
Time Frame
Once histology is available usually takes 10-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and over Referral for surveillance, or diagnostic colonoscopy Ability to give informed consent Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian P Saunders, MD
Organizational Affiliation
St Mark's Hospital, Northwest London Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthWest London Hospitals - NOrthwick park hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31836474
Citation
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.
Results Reference
derived

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Detection in Tandem Endocuff Cap Trial

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