Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate. (DiscoveryIII)

Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With Artificial Intelligence Assisted Polyp Detection (Discovery System) on Adenoma Detection Rate. 'Discovery III Study'

Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.

Study Overview

• Status: Recruiting
• Conditions: Adenoma; Artificial Intelligence; Colonoscopy; Colorectal Polyp
• Intervention / Treatment: Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)

Detailed Description

Rationale: Colonoscopy is the gold standard for CRC screening. The adenoma detection rate (ADR) is the most important quality parameter for colonoscopy, because of its inverse association with the risk of interval CRC. Yet, the adenoma miss rate (AMR) in conventional colonoscopy is reported in meta-analyses to vary between 22-26%. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colonic mucosa during the procedure. To increase the adenoma detection rate (ADR), new polyp/adenoma detection systems based on artificial intelligence (AI) have been developed, i.e., computer assisted detection (CADe). However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions. Therefore, we hypothesize that ADR can further be improved by combining a CADe system, the Discovery system, with a behind the fold (BTF) visualization technique, the G-Eye.

Study design: International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135). All subjects will be undergoing colonoscopy with a combined BFT and CADe assisted approach. Outcomes will be corrected for confounders using regression modeling.

Study population: 194 Adult patients (>18 years) from 3 hospitals, scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy. Exclusion criteria: inflammatory bowel disease (IBD), known polyp or tumor upon referral, therapeutic procedure (e.g. endoscopic mucosal resection), prior surgical resection of any portion of the colon, American Society of Anesthesiologists score of ≥3, Inadequately corrected anticoagulation disorders or anticoagulation medication use, inability to provide informed consent.

Main study endpoints: The primary objective of the present study is to compare ADR between CADe assisted and a combined BTF/CADe assisted colonoscopy. Secondary objectives include advanced neoplasia rate (including advanced adenomas and/or CRC), polyp detection rate, size and histopathology, mean number of polyps per patient, procedure times, bowel cleaning levels, adverse events, inter-operator variability.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Eligible patients who are scheduled for surveillance colonoscopy will undergo one BFT and CADe assisted colonoscopy. There will be no burden for participants regarding the colonoscopy procedure. Colonoscopy is a commonly performed procedure, and the overall serious adverse event rate is low with an estimated risk 2.8 per 1000 colonoscopies. The risk of experiencing a (serious) adverse event with G-Eye and Discovery guided colonoscopy is believed to be equivalent to conventional colonoscopy. The benefit for patients is a higher likelihood of lesion detection during colonoscopy.

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michiel JH Maas, Msc; Phone Number: +31 629647175; Email: Michiel.maas@Radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Recruiting
      • Radboud university medical center Nijmegen
      • Contact: Michiel HJ Maas, MSc; Phone Number: +31 629647175; Email: Michiel.maas@Radboudumc.nl
      • Principal Investigator: Peter D. Siersema, prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patients (>18 years)
• Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.

Exclusion Criteria:

• Inflammatory bowel disease (IBD)
• Known polyp or tumor upon referral
• Therapeutic procedure (e.g., endoscopic mucosal resection)
• Prior surgical resection of any portion of the colon
• American Society of Anesthesiologists score of ≥3
• Inadequately corrected anticoagulation disorder or anticoagulation medication use
• inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: colonoscopy with a combined BFT and CADe assisted approach; This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy.

Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe); All participants will be subjected to a colonoscopy procedure, assisted by both G-eye balloon and the Discovery CADe system. Standard of care regarding the colonoscopy procedure will be applied to all study subjects. Any lesions detected during the procedure will be removed directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate (ADR)	Calculated as the number of patients in whom at least one adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure.	30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced adenoma detection rate (AADR).	calculated as the number of patients in whom at least one advanced adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure	30 days after procedure
Polyp Detection Rate	calculated as the number of patients in whom at least one polyp is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure	30 days after procedure
Sessile detection Rate	calculated as the number of patients in whom at least one SSL is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure	30 days after procedure
Indication specific ADR,	ADR specific for screening, diagnostic, or surveillance	30 days after procedure
Mean number of adenomas detected per patient	Mean number of adenomas detected per patient	30 days after procedure
Mean number of polyps detected per patient	Mean number of polyps detected per patient	30 days after procedure
Number of sessile serrated lesions	Number of sessile serrated lesions	30 days after procedure
Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD	Number of advanced adenomas (adenomas ≥ 10 mm and/or with a villous component and/or with HGD	30 days after procedure
Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm	Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm	During procedure
Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum;	Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum;	During procedure
Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)	Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III)	During procedure
Histopathological characteristics of the lesion according to the Vienna classification	Histopathological characteristics of the lesion according to the Vienna classification	30 days after procedure
ADR of the first 20% of patients that have undergone colonoscopy by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial	ADR of the first 20% of patients that have undergone colonoscopy by each endoscopist will be compared with the final 20% of patients in each arm to identify any changes in ADR throughout the trial	At end of study
Bowel cleansing	Using the Boston Bowel Prep Scale	During procedure
Cecal intubation rate (CIR)	Cecal intubation rate (CIR)	During procedure
Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)	Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time)	During procedure
Severe) adverse events (S)AEs up to 30 days post-procedure	SAEs will be subcategorized into colonoscopy related, cardiac (cardiac ischemia, heart failure, arrhythmia, other) pulmonary (exacerbation COPD, infectious, other), neurological (stroke, cerebrovascular accident, bleeding, other), and other (surgical interventions etc.)	30 days after procedure
Gloucester Comfort Scale score and analgesia use	Gloucester Comfort Scale score and analgesia use	During procedure
Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines	Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines	30 days after procedure

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: PENTAX Europe GmbH
• Investigators: Principal Investigator: Peter D Siersema, Prof, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Adenoma; Polyps
• Other Study ID Numbers: NL80004.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset used during this study is available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No