Discovery: Pentax* Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting - The Discovery II Study. A randomized clinical trial.

Discovery: Pentax* Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting - The Discovery II Study. A randomized clinical trial. - The Discovery II Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49600

Enrollment

Registered

2020-07-14

Start date

2021-05-27

Completion date

Unknown

Last updated

2025-08-18

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

Exclusion criteria

Exclusion criteria: - Known colorectal tumor or polyp on referral; - Referral for a therapeutic procedure (i.e. endoscopic mucosal resection, intervention for lower gastro-intestinal bleeding, etc.); - Inadequately corrected anticoagulation disorders or anticoagulation medication use; - American Society of Anesthesiologists (ASA) score >= 3; - Known or suspected inflammatory bowel disease; - Inability to provide informed consent.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the adenoma detection rate (ADR), which 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 (e.g. PCSC or CC).	—

Secondary

Measure	Time frame
- The 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 (e.g. PCSC or CC); - The mean number of adenomas detected per patient; - The mean number of polyps detected per patient; - The number of sessile serrated lesions; - The number of advanced adenomas (i.e. adenomas >= 10 mm and/or harbouring a villous component and/or containing HGD; - Size of the lesion; o 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion; o Caecum, ascending, transverse, descending, sigmoid, rectum - Morphological characteristics of the lesion using the Paris classification; o Ip, Is, IIa, IIb, IIc, III - Histopathological characteristics of the lesion according to the Vienna classification; - The ADR of the first 20% of patients scoped 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 levels using the BBPS; - Procedure times with both techniques (i.e. total procedure time, mean polypectomy time and withdrawal time); - (Severe) adverse events up to 30 days post-procedure; - Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines; - The number of false positives; - The reason why a notification is assessed as false positive by the endoscopist (i.e. bubbles, fecal material, etc.); - The number of false negatives. Other study parameters - Gender - Age - Smoking status - BMI - Type of endoscope used - Family history of (colorectal) cancer	—

Measure

Time frame

- The 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 (e.g. PCSC or CC); - The mean number of adenomas detected per patient; - The mean number of polyps detected per patient; - The number of sessile serrated lesions; - The number of advanced adenomas (i.e. adenomas >= 10 mm and/or harbouring a villous component and/or containing HGD; - Size of the lesion; o 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Location of the lesion; o Caecum, ascending, transverse, descending, sigmoid, rectum - Morphological characteristics of the lesion using the Paris classification; o Ip, Is, IIa, IIb, IIc, III - Histopathological characteristics of the lesion according to the Vienna classification; - The ADR of the first 20% of patients scoped 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 levels using the BBPS; - Procedure times with both techniques (i.e. total procedure time, mean polypectomy time and withdrawal time); - (Severe) adverse events up to 30 days post-procedure; - Post-colonoscopy surveillance intervals when applying European and US surveillance guidelines; - The number of false positives; - The reason why a notification is assessed as false positive by the endoscopist (i.e. bubbles, fecal material, etc.); - The number of false negatives. Other study parameters - Gender - Age - Smoking status - BMI - Type of endoscope used - Family history of (colorectal) cancer

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Countries

Netherlands

Outcome results