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Colon PolypNCT03814369

AmplifEYE Colonoscopy vs Standard Colonoscopy

A study testing AmplifEYE in people with Colon Polyp and Adenoma Colon, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Colon Polyp, Adenoma Colon, Serrated Polyp
What is being tested?
AmplifEYE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
1 siteHong Kong
Study dates
1 Mar 2017to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Colonic strictures
  • History of bowel surgery
  • Per-rectal bleeding within six weeks
  • Inflammatory bowel disease
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Medicine, Queen Elizabeth Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the detailed 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.

Being tested
AmplifEYE
Keywords
colonoscopy, adenoma detection rate, colorectal cancer screening, new technology
Medical subject headings
Colonic Polyps, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmplifEYEDevice

    AmplifEYE colonoscopy

Study groups in NCT03814369
Study groupRoleWhat they receive
AmplifEYE colonoscopyExperimentalColonoscopy performed with AmplifEYE equipped
Receives: Device: AmplifEYE
Standard colonoscopyNo interventionStandard colonoscopy performed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma detection rate

    number of patients in whom at least one adenoma could be found

    Measured: 1 day

Secondary outcomes (4)

  1. Polyp detection rate

    number of patients in whom at least one polyp could be found

    Measured: 1 day

  2. Serrated polyp detection rate

    number of patients in whom at least one serrated polyp could be found

    Measured: 1 day

  3. caecal intubation rate

    number of patients in whom caecal intubation is acheived

    Measured: 1 day

  4. caecal intubation time

    time beginning with the insertion of the colonoscope until reaching the caecum

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start1 Mar 2017
  3. Primary completion30 Jun 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814369
Sponsor's protocol ID
amplifeye
Status last verified
Mar 2019
First submitted
20 Jan 2019
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24047059

  • 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.

    PubMed 8978338

  • 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.

    PubMed 24693890

  • 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.

    PubMed 20463339

  • 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.

    PubMed 25470133

  • 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.

    PubMed 26171436

  • 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.

    PubMed 26674360

Questions about this trial

What is this clinical trial studying?

A study testing AmplifEYE in people with Colon Polyp and Adenoma Colon, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma detection rate (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814369, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

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