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

NCT ID: NCT04107376

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Adenoma Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Retroviewing endoscopy (RVE)

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.

Group Type EXPERIMENTAL

Retroviewing endoscopy

Intervention Type DIAGNOSTIC_TEST

The colon is inspected with a new retroviewing endoscope

standard forward viewing endoscopy (SFVE)

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.

Group Type ACTIVE_COMPARATOR

Retroviewing endoscopy

Intervention Type DIAGNOSTIC_TEST

The colon is inspected with a new retroviewing endoscope

Interventions

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Retroviewing endoscopy

The colon is inspected with a new retroviewing endoscope

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* screening colonoscopy
* 18 years of age

Exclusion Criteria

* inflammatory bowel disease
* inadequate bowel preparation
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Timo Rath

Prof. Dr. Timo Rath

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Erlangen

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Timo Rath, MD

Role: CONTACT

+49 9131 85 35000

Facility Contacts

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Timo Rath, Professor of Endoscopy

Role: primary

49 9131 ext. 85 45041

Other Identifiers

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Ludwig Demling Endoscopy

Identifier Type: -

Identifier Source: org_study_id

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