AmplifEYE Colonoscopy vs Standard Colonoscopy

Colonic Neoplasms Clinical Trial

Official title:

Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814369
• Other study ID #: amplifeye
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: March 2019
• Source: Queen Elizabeth Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: November 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colon Polyp
• Colonic Neoplasms
• Polyps
• Serrated Polyp

Intervention

Device:
• AmplifEYE
AmplifEYE colonoscopy

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, Queen Elizabeth Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital, Hong Kong	Our Lady of Maryknoll Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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. — View Citation

Floer M, Biecker E, Fitzlaff R, Röming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Ströbel 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	number of patients in whom at least one adenoma could be found	1 day
Secondary	Polyp detection rate	number of patients in whom at least one polyp could be found	1 day
Secondary	Serrated polyp detection rate	number of patients in whom at least one serrated polyp could be found	1 day
Secondary	caecal intubation rate	number of patients in whom caecal intubation is acheived	1 day
Secondary	caecal intubation time	time beginning with the insertion of the colonoscope until reaching the caecum	1 day