Detection in Tandem Endocuff Cap Trial (DETECT)

London North West Healthcare NHS Trust

Status: Completed

Conditions: Adenomas Serrated; Colonic Neoplasms; Colo-rectal Cancer; Colon Adenoma

Treatments: Device: Endocuff; Device: cap assisted colonoscopy (CAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03254498

RD15/061

Details and patient eligibility

About

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

Enrollment: 154 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups, including a placebo group

Endocuff assisted colonoscopy

Active Comparator group

Description:

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

Treatment:

Device: Endocuff

Cap assisted colonoscopy

Placebo Comparator group

Description:

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

Treatment:

Device: cap assisted colonoscopy (CAC)