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AmplifEYE Colonoscopy vs Standard Colonoscopy

Q

Queen Elizabeth Hospital, Hong Kong

Status

Completed

Conditions

Colonic Neoplasms
Serrated Polyp
Colon Polyp
Adenoma Colon

Treatments

Device: AmplifEYE

Study type

Interventional

Funder types

Other

Identifiers

NCT03814369
amplifeye

Details and patient eligibility

About

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.

Full 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.

Enrollment

355 patients

Sex

All

Ages

50 to 79 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

355 participants in 2 patient groups

AmplifEYE colonoscopy
Experimental group
Description:
Colonoscopy performed with AmplifEYE equipped
Treatment:
Device: AmplifEYE
Standard colonoscopy
No Intervention group
Description:
Standard colonoscopy performed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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