An observational study in Colonic Polyp, sponsored by Pentax Medical. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Pentax Medical · Observational
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.
This study's planned enrollment of 60 is below the median of 475 across 92 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Pentax Medical is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.
Exclusion Criteria:
Routine colonoscopy using the EFOV lens in the colonoscope.
Cecal Intubation Rate
The proportion of procedures in which the cecum was reached.
Time frame: Day 1
Procedure Time
Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.
Time frame: Day 1
Ileum Intubation Rate
Success rate of reaching the Ileum.
Time frame: Day 1
Therapeutic Intervention Success Rate
The ability to collect a biopsy or remove a polyp.
Time frame: Day 1
Mean number of polyps per coloscopy and its detection rate
Count of number of polyps seen during colonoscopy
Time frame: Day 1
Mean number of adenomas and its detection rate
Count of number of adenomas/sessile serrate lesions defined by pathology
Time frame: Day 14
Mean number of sessile serrate lesions and its detection rate
Count of number of adenomas/sessile serrate lesions defined by pathology
Time frame: Day 14
Patient Satisfaction Survey
During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure.
Time frame: Day 14
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Pentax Medical