NCT04472741

Brief Summary

Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its intended purpose)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,114

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

March 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.6 years

First QC Date

July 11, 2020

Last Update Submit

February 8, 2021

Conditions

Adenoma Detection Rate

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    adenoma counts

    within 45 minutes of examination

Secondary Outcomes (1)

  • time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS

    within 45 minutes of examination

Study Arms (3)

FUSE

OTHER

wide angle colonoscope

Device: difference between colonoscopes

HD Pentax i10 colonoscopes

OTHER

SFV instrument

Device: difference between colonoscopes

Endocuff

OTHER

Cuff on SFV

Device: difference between colonoscopes

Interventions

difference between colonoscopesDEVICE

patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff

EndocuffFUSEHD Pentax i10 colonoscopes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patient fit for ambulatory colonoscopy

You may not qualify if:

  • for Endocuff stricturing divertculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Geyer Martin, Director and Principal investigator

Study Record Dates

First Submitted

July 11, 2020

First Posted

July 15, 2020

Study Start

March 1, 2015

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share