Discovery: Pentax* Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting - The Discovery I Study

Discovery: Pentax* Computer-aided Detection to Improve Adenoma Detection in a Real-time Setting - The Discovery I Study - The Discovery I Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50010

Enrollment

Registered

2020-07-14

Start date

2020-09-24

Completion date

Unknown

Last updated

2024-04-15

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 either 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 PDR, defined as the number of colonoscopies in which >=1 polyp is detected divided by the total number of colonoscopies.	—

Secondary

Measure	Time frame
- Mean number of polyps - Mean number of adenomas - ADR - Polyp location Caecum, ascending, transverse, descending, sigmoid, rectum - Polyp shape according to the Paris classification Ip, Is, IIa, IIb, IIc, III - Polyp size 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Polyp type Adenoma, sessile serrated lesion, hyperplastic polyp - Withdrawal time (minutes) - Procedure time (minutes) - Boston Bowel Preparation Scale (3-9) - (Serious) Adverse events - Endoscopists* evaluation of: Number of polyps that would have been missed without the CADe-system; - Endoscopists* subjective evaluation on a Likert scale of: User friendliness	—

Measure

Time frame

- Mean number of polyps - Mean number of adenomas - ADR - Polyp location Caecum, ascending, transverse, descending, sigmoid, rectum - Polyp shape according to the Paris classification Ip, Is, IIa, IIb, IIc, III - Polyp size 0-5 mm, 6-10 mm, 10-20 mm, >20 mm - Polyp type Adenoma, sessile serrated lesion, hyperplastic polyp - Withdrawal time (minutes) - Procedure time (minutes) - Boston Bowel Preparation Scale (3-9) - (Serious) Adverse events - Endoscopists* evaluation of: Number of polyps that would have been missed without the CADe-system; - Endoscopists* subjective evaluation on a Likert scale of: User friendliness

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Countries

Netherlands

Outcome results