NCT04837599

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

April 6, 2021

Last Update Submit

April 13, 2021

Conditions

Colonic PolypAdenoma

Keywords

artificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Endoscopy time

    measurement of ascent, descent and intervention time during colonoscopy

    within 45 minutes of examination

Secondary Outcomes (1)

  • polyp and adenoma detetction rate PDR and ADR

    within 45 minutes of examination

Other Outcomes (1)

  • Medication dosage

    withn 45 minutes of examination

Study Arms (4)

Pentax i 10

NO INTERVENTION

Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence

Pentax i 10 with artificial intelligence Discovery TM

ACTIVE COMPARATOR

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

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

Pentax i 10 with Endocuff TM

ACTIVE COMPARATOR

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

Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM

ACTIVE COMPARATOR

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

Interventions

Discovery TM of Pentax medical on/off in colonoscopyDEVICE

on the monitor artificial integlligence Discovery can be switched on or off.

Also known as: Endocuff mounted yes/no
Pentax i 10 with Endocuff TMPentax i 10 with Endocuff TM and artificial intelligence Discovery TMPentax i 10 with artificial intelligence Discovery TM

Eligibility Criteria

Age15 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients referred and fit for an ambulant colonoscopy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin Geyer

Wettingen, Canton of Aargau, 5430, Switzerland

Location

MeSH Terms

Conditions

Colonic PolypsAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr med. Geyer Martin, Principal investigator

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2022

Study Completion

October 31, 2022

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)