AmplifEYE Colonoscopy vs Standard Colonoscopy

NCT ID: NCT03814369

Last Updated: 2019-03-26

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

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-11-30

Brief Summary

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Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.

Detailed Description

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This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All study team members will have a prior run-in phase of performing at least 5 AmplifEYE colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time, colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each group.

Conditions

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Colon Polyp Adenoma Colon Serrated Polyp Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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AmplifEYE colonoscopy

Colonoscopy performed with AmplifEYE equipped

Group Type EXPERIMENTAL

AmplifEYE

Intervention Type DEVICE

AmplifEYE colonoscopy

Standard colonoscopy

Standard colonoscopy performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AmplifEYE

AmplifEYE colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged between 50 to 79 years old
* Scheduled for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria

* Colonic strictures
* History of bowel surgery
* Per-rectal bleeding within six weeks
* Inflammatory bowel disease
* Pregnancy
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Our Lady of Maryknoll Hospital

OTHER

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Sze Shun Fung

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shun Fung Sze, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Queen Elizabeth Hospital

Locations

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Department of Medicine, Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.

Reference Type BACKGROUND
PMID: 24047059 (View on PubMed)

Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.

Reference Type BACKGROUND
PMID: 8978338 (View on PubMed)

Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.

Reference Type BACKGROUND
PMID: 24693890 (View on PubMed)

Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.

Reference Type BACKGROUND
PMID: 20463339 (View on PubMed)

Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

Reference Type BACKGROUND
PMID: 25470133 (View on PubMed)

Sawatzki M, Meyenberger C, Marbet UA, Haarer J, Frei R. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population. Endosc Int Open. 2015 Jun;3(3):E236-9. doi: 10.1055/s-0034-1391418. Epub 2015 Feb 27.

Reference Type BACKGROUND
PMID: 26171436 (View on PubMed)

van Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16.

Reference Type BACKGROUND
PMID: 26674360 (View on PubMed)

Other Identifiers

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amplifeye

Identifier Type: -

Identifier Source: org_study_id

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