Detection in Tandem Endocuff Cap Trial

Colonic Neoplasms Clinical Trial

— DETECT  

Official title:

Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254498
• Other study ID #: RD15/061
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 17, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomas Serrated
• Colo-rectal Cancer
• Colon Adenoma
• Colonic Neoplasms
• Colorectal Neoplasms
• Rectal Neoplasms

Intervention

Device:
• Endocuff
It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
• cap assisted colonoscopy (CAC)
cap assisted colonoscopy (CAC)

Locations

Country	Name	City	State
United Kingdom	NorthWest London Hospitals - NOrthwick park hospital	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	comparison of surveillance intervals	To compare any surveillance interval difference between CAC and EAC	Once histology is available usually takes 10-14 days
Primary	Adenoma miss rate	Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E	1 day
Secondary	Mean adenoma per procedure	Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.	1 day
Secondary	Endocuff or cap exchange	Number of times Cap or Endocuff are removed to complete the procedure	1 day
Secondary	Ceacal intubation and withdrawal time	Comparison of caecal intubation and withdrawal time	1 day
Secondary	miss rate of advanced polyps	Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC	1 day
Secondary	Comfort score	Comparison of patient comfort score between CAC and EAC	1 day