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Artificial Intelligence Performance in Colonoscopy in Daily Practice

Primary Purpose

Colonic Polyp, Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Discovery TM of Pentax medical on/off in colonoscopy
Sponsored by
Gastroenterologie Baden-Wettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp focused on measuring artificial intelligence

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

  • none

Sites / Locations

  • Martin Geyer

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pentax i 10

Pentax i 10 with artificial intelligence Discovery TM

Pentax i 10 with Endocuff TM

Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM

Arm Description

Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence

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

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

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.

Outcomes

Primary Outcome Measures

Endoscopy time
measurement of ascent, descent and intervention time during colonoscopy

Secondary Outcome Measures

polyp and adenoma detetction rate PDR and ADR
counts of polypes and their location in the colon and their histology

Full Information

First Posted
April 6, 2021
Last Updated
April 13, 2021
Sponsor
Gastroenterologie Baden-Wettingen
Collaborators
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT04837599
Brief Title
Artificial Intelligence Performance in Colonoscopy in Daily Practice
Official Title
Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gastroenterologie Baden-Wettingen
Collaborators
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Adenoma
Keywords
artificial intelligence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pentax i 10
Arm Type
No Intervention
Arm Description
Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence
Arm Title
Pentax i 10 with artificial intelligence Discovery TM
Arm Type
Active Comparator
Arm Description
Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence
Arm Title
Pentax i 10 with Endocuff TM
Arm Type
Active Comparator
Arm Description
Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate.
Arm Title
Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Discovery TM of Pentax medical on/off in colonoscopy
Other Intervention Name(s)
Endocuff mounted yes/no
Intervention Description
on the monitor artificial integlligence Discovery can be switched on or off.
Primary Outcome Measure Information:
Title
Endoscopy time
Description
measurement of ascent, descent and intervention time during colonoscopy
Time Frame
within 45 minutes of examination
Secondary Outcome Measure Information:
Title
polyp and adenoma detetction rate PDR and ADR
Description
counts of polypes and their location in the colon and their histology
Time Frame
within 45 minutes of examination
Other Pre-specified Outcome Measures:
Title
Medication dosage
Description
Dosage of Propofol and Buscopan
Time Frame
withn 45 minutes of examination

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients referred and fit for an ambulant colonoscopy Exclusion Criteria: none
Facility Information:
Facility Name
Martin Geyer
City
Wettingen
State/Province
Aargau
ZIP/Postal Code
5430
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Geyer, MD
Phone
0562227292
Email
geyer@gastro-bw.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Artificial Intelligence Performance in Colonoscopy in Daily Practice

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