Detection in Tandem Endocuff Cap Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Colonic Neoplasms Adenomas Serrated Colo-rectal Cancer Colon Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Endocuff assisted colonoscopy

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

Group Type ACTIVE_COMPARATOR

Endocuff

Intervention Type DEVICE

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

Cap assisted colonoscopy

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

Group Type PLACEBO_COMPARATOR

cap assisted colonoscopy (CAC)

Intervention Type DEVICE

cap assisted colonoscopy (CAC)

Interventions

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Endocuff

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

Intervention Type DEVICE

cap assisted colonoscopy (CAC)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No