AmplifEYE Colonoscopy vs Standard Colonoscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Polyp, Adenoma Colon, Serrated Polyp, Colonic Neoplasms

Intervention / Treatment
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* Device: AmplifEYE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AmplifEYE colonoscopy<br>Colonoscopy performed with AmplifEYE equipped | Device: AmplifEYE<br>* AmplifEYE colonoscopy<br>|
| No Intervention: Standard colonoscopy<br>Standard colonoscopy performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | number of patients in whom at least one adenoma could be found | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | number of patients in whom at least one polyp could be found | 1 day | 
| Serrated polyp detection rate | number of patients in whom at least one serrated polyp could be found | 1 day | 
| caecal intubation rate | number of patients in whom caecal intubation is acheived | 1 day | 
| caecal intubation time | time beginning with the insertion of the colonoscope until reaching the caecum | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, adenoma detection rate, colorectal cancer screening, new technology