Clinical trial NCT03814369: AmplifEYE Colonoscopy vs Standard Colonoscopy
Official title: Use of AmplifEYE-assisted Colonoscopy Compared to Standard Colonoscopy in Polyp and Adenoma Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Adenoma Colon
Serrated Polyp
Colonic Neoplasms
Keywords: colonoscopy
adenoma detection rate
colorectal cancer screening
new technology
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: Our Lady of Maryknoll Hospital
First posted: 2019-01-24
Enrollment: 355
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 1 day
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 1 day
measure: Serrated polyp detection rate
timeFrame: 1 day
measure: caecal intubation rate
timeFrame: 1 day
measure: caecal intubation time
timeFrame: 1 day
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, Queen Elizabeth Hospital
Study officials:
affiliation: Department of Medicine, Queen Elizabeth Hospital
name: Shun Fung Sze, MBBS
role: PRINCIPAL_INVESTIGATOR
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