DETECT: Detection in Tandem Endocuff Cap Trial

• Sponsor: London North West Healthcare NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03254498
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms; Adenomas Serrated; Colo-rectal Cancer; Colon Adenoma	Device: Endocuff; Device: cap assisted colonoscopy (CAC)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endocuff assisted colonoscopy Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.	Device: Endocuff; It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
Placebo Comparator: Cap assisted colonoscopy Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.	Device: cap assisted colonoscopy (CAC); cap assisted colonoscopy (CAC)

Outcome Measures

Primary Outcome Measures

1. Adenoma miss rate [1 day]

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

Secondary Outcome Measures

1. Mean adenoma per procedure [1 day]

   Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.

2. Endocuff or cap exchange [1 day]

   Number of times Cap or Endocuff are removed to complete the procedure

3. Ceacal intubation and withdrawal time [1 day]

   Comparison of caecal intubation and withdrawal time

4. miss rate of advanced polyps [1 day]

   Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC

5. Comfort score [1 day]

   Comparison of patient comfort score between CAC and EAC

Other Outcome Measures

1. comparison of surveillance intervals [Once histology is available usually takes 10-14 days]

   To compare any surveillance interval difference between CAC and EAC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthWest London Hospitals - NOrthwick park hospital	Harrow	Middlesex	United Kingdom	HA1 3UJ

Sponsors and Collaborators

• London North West Healthcare NHS Trust

Investigators

• Principal Investigator: Brian P Saunders, MD, St Mark's Hospital, Northwest London Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: London North West Healthcare NHS Trust
• ClinicalTrials.gov Identifier: NCT03254498
• Other Study ID Numbers: RD15/061
• First Posted: Aug 18, 2017
• Last Update Posted: Aug 18, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by London North West Healthcare NHS Trust: colonic adenoma; serrated polyps; caecal intubation time; withdrawal time; polyp miss rate
• Additional relevant MeSH terms: Adenoma; Colonic Neoplasms

Study Results

No Results Posted as of Aug 18, 2017