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OpenTrials
Completed

NCT Number: NCT03814369

AmplifEYE Colonoscopy vs Standard Colonoscopy

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.

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Key information

Conditions

Colon Polyp Adenoma Colon Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Serrated Polyp

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Queen Elizabeth Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmplifEYE

Device

AmplifEYE colonoscopy

Primary outcomes

  1. Adenoma detection rate

    Time frame: 1 day

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

Secondary outcomes

  1. Polyp detection rate

    Time frame: 1 day

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

  2. Serrated polyp detection rate

    Time frame: 1 day

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

  3. caecal intubation rate

    Time frame: 1 day

    number of patients in whom caecal intubation is acheived

  4. caecal intubation time

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Queen Elizabeth Hospital, Hong Kong

Other

Collaborators

  • Our Lady of Maryknoll Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2019
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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