Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
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
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedSeptember 27, 2019
September 1, 2019
10 months
September 25, 2019
September 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
calculation of the adenoma detection rate in each arm
8 months
Secondary Outcomes (3)
Polyp detection rate
8 months
Mean number of adenomas per patient
8 months
Withdrawal time
8 months
Study Arms (2)
Retroviewing endoscopy (RVE)
EXPERIMENTALWithdrawal 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.
standard forward viewing endoscopy (SFVE)
ACTIVE COMPARATORWithdrawal 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.
Interventions
The colon is inspected with a new retroviewing endoscope
Eligibility Criteria
You may qualify if:
- screening colonoscopy
- years of age
You may not qualify if:
- inflammatory bowel disease
- inadequate bowel preparation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Erlangen
Erlangen, 91054, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Timo Rath
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
December 1, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
September 27, 2019
Record last verified: 2019-09