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

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* - Discovery III study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51795

Enrollment

Registered

2022-01-26

Start date

2022-03-31

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal adenomas and polyps

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - 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 - Inflammatory bowel disease (IBD) - inability to provide informed consent.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the 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.	—

Secondary

Measure	Time frame
- 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 - PDR, 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 - TSDR, 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 - Indication specific ADR, i.e., ADR specific for screening, diagnostic, or surveillance - Mean number of adenomas detected per patient - Mean number of polyps detected per patient - Number of sessile serrated lesions - Number of advanced adenomas (adenomas >= 10 mm and/or with a villous component and/or with HGD - Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum; - Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III) - Histopathological characteristics of the lesion according to the Vienna classification - 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 - Bowel cleansing using the BBPS - Cecal intubation rate (CIR) - Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time) - (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),	—

Measure

Time frame

- 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 - PDR, 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 - TSDR, 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 - Indication specific ADR, i.e., ADR specific for screening, diagnostic, or surveillance - Mean number of adenomas detected per patient - Mean number of polyps detected per patient - Number of sessile serrated lesions - Number of advanced adenomas (adenomas >= 10 mm and/or with a villous component and/or with HGD - Size of the lesion subdivided in categories 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion: cecum, ascending colon, transverse colon, descending colon, sigmoid, rectum; - Morphological characteristics of the lesion using the Paris classification (Ip, Is, IIa, IIb, IIc, III) - Histopathological characteristics of the lesion according to the Vienna classification - 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 - Bowel cleansing using the BBPS - Cecal intubation rate (CIR) - Procedure times with both techniques (i.e., total procedure time, mean polypectomy time and withdrawal time) - (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),

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Countries

Netherlands

Outcome results