Artificial Intelligence Performance in Colonoscopy in Daily Practice

Study Overview
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Brief Summary
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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).

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

Official Title
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Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without

Conditions
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Colonic Polyp, Adenoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients referred and fit for an ambulant colonoscopy Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pentax i 10<br>Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence | |
| Active Comparator: Pentax i 10 with artificial intelligence Discovery TM<br>Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence | Device: Discovery TM of Pentax medical on/off in colonoscopy<br>* on the monitor artificial integlligence Discovery can be switched on or off.<br>* Other names: Endocuff mounted yes/no;|
| Active Comparator: Pentax i 10 with Endocuff TM<br>Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate. | Device: Discovery TM of Pentax medical on/off in colonoscopy<br>* on the monitor artificial integlligence Discovery can be switched on or off.<br>* Other names: Endocuff mounted yes/no;|
| Active Comparator: Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM<br>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. | Device: Discovery TM of Pentax medical on/off in colonoscopy<br>* on the monitor artificial integlligence Discovery can be switched on or off.<br>* Other names: Endocuff mounted yes/no;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopy time | measurement of ascent, descent and intervention time during colonoscopy | within 45 minutes of examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp and adenoma detetction rate PDR and ADR | counts of polypes and their location in the colon and their histology | within 45 minutes of examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence