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Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Primary Purpose

Adenoma, Polyps

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Retroviewing endoscopy
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma focused on measuring retroviewing, endoscopy, adenoma detection, polyp detection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • screening colonoscopy
  • 18 years of age

Exclusion Criteria:

  • inflammatory bowel disease
  • inadequate bowel preparation

Sites / Locations

  • University Hospital ErlangenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retroviewing endoscopy (RVE)

standard forward viewing endoscopy (SFVE)

Arm Description

Withdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.

Withdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.

Outcomes

Primary Outcome Measures

Adenoma detection rate
calculation of the adenoma detection rate in each arm

Secondary Outcome Measures

Polyp detection rate
polyp detection rate in each arm
Mean number of adenomas per patient
Mean number of adenomas per patient in each arm
Withdrawal time
Withdrawal time in each arm

Full Information

First Posted
September 25, 2019
Last Updated
September 26, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04107376
Brief Title
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
Official Title
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

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

5. Study Description

Brief Summary
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Polyps
Keywords
retroviewing, endoscopy, adenoma detection, polyp detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retroviewing endoscopy (RVE)
Arm Type
Experimental
Arm Description
Withdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.
Arm Title
standard forward viewing endoscopy (SFVE)
Arm Type
Active Comparator
Arm Description
Withdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Retroviewing endoscopy
Intervention Description
The colon is inspected with a new retroviewing endoscope
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
calculation of the adenoma detection rate in each arm
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
polyp detection rate in each arm
Time Frame
8 months
Title
Mean number of adenomas per patient
Description
Mean number of adenomas per patient in each arm
Time Frame
8 months
Title
Withdrawal time
Description
Withdrawal time in each arm
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: screening colonoscopy 18 years of age Exclusion Criteria: inflammatory bowel disease inadequate bowel preparation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timo Rath, MD
Phone
+49 9131 85 35000
Email
timo.rath@uk-erlangen.de
Facility Information:
Facility Name
University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Rath, Professor of Endoscopy
Phone
49 9131
Ext
85 45041
Email
timo.rath@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

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