Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Artificial Intelligence Performance in Colonoscopy in Daily Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837599
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Geyer Martin, Gastroenterologie Baden-Wettingen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Colonic Polyp Adenoma Device: Discovery TM of Pentax medical on/off in colonoscopy Not Applicable

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.

  1. endpoint is time gain in the different phase of the colonoscopy
  2. endpoint is adenoma detection rate (ADR)
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Pentax i 10
Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence
Active Comparator: Pentax i 10 with artificial intelligence Discovery TM
Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence
 Device: Discovery TM of Pentax medical on/off in colonoscopy
on the monitor artificial integlligence Discovery can be switched on or off.
Other Name: Endocuff mounted yes/no
Active Comparator: Pentax i 10 with Endocuff TM
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
on the monitor artificial integlligence Discovery can be switched on or off.
Other Name: Endocuff mounted yes/no
Active Comparator: Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM
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
on the monitor artificial integlligence Discovery can be switched on or off.
Other Name: Endocuff mounted yes/no


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endoscopy time [ Time Frame: within 45 minutes of examination ]
    measurement of ascent, descent and intervention time during colonoscopy


Secondary Outcome Measures :
  1. polyp and adenoma detetction rate PDR and ADR [ Time Frame: within 45 minutes of examination ]
    counts of polypes and their location in the colon and their histology


Other Outcome Measures:
  1. Medication dosage [ Time Frame: withn 45 minutes of examination ]
    Dosage of Propofol and Buscopan


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

  • none
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837599


Locations
Layout table for location information
Switzerland
Martin Geyer
Wettingen, Aargau, Switzerland, 5430
Contact: Martin Geyer, MD    0562227292    geyer@gastro-bw.ch   
Sponsors and Collaborators
Gastroenterologie Baden-Wettingen
Ludwig-Maximilians - University of Munich
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Geyer Martin, Dr med. Geyer Martin, Principal investigator, Gastroenterologie Baden-Wettingen
ClinicalTrials.gov Identifier: NCT04837599    
Other Study ID Numbers: Gastro BW 1
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geyer Martin, Gastroenterologie Baden-Wettingen:
artificial intelligence
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical