Artificial Intelligence Performance in Colonoscopy in Daily Practice

Gastroenterologie Baden-Wettingen

Status: Unknown

Conditions: Colonic Polyp; Adenoma

Treatments: Device: Discovery TM of Pentax medical on/off in colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04837599

Gastro BW 1

Details and patient eligibility

About

randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).

The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).

Full description

From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.

1. endpoint is time gain in the different phase of the colonoscopy
2. endpoint is adenoma detection rate (ADR)

Enrollment: 1,100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients referred and fit for an ambulant colonoscopy

Exclusion criteria

• none

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 4 patient groups

Pentax i 10

No Intervention group

Description:

Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence

Pentax i 10 with artificial intelligence Discovery TM

Active Comparator group

Description:

Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence

Treatment:

Device: Discovery TM of Pentax medical on/off in colonoscopy

Pentax i 10 with Endocuff TM

Active Comparator group

Description:

Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate.

Treatment:

Device: Discovery TM of Pentax medical on/off in colonoscopy

Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM

Active Comparator group

Description:

Endocuff cap is mounted on the tip of the endoscope and artificial intelligence is activated on the monitor. hypothesis is that probably artificial intelligence and Endocuff combined potentiate their effect.

Treatment:

Device: Discovery TM of Pentax medical on/off in colonoscopy