N/A
N=612
Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
Colorectal Adenoma · Colorectal Polyp · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03560128 ↗Enrolled (actual)
612
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Adenomas Detected Per Colonoscopy (APC). — 1.63; 1.51 adenomas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endocuff Vision device (Device); AmplifEYE device (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adenomas Detected Per Colonoscopy (APC). |
1.63; 1.51 | — |
| SECONDARY Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) |
164; 159; 229; 231 | — |
| SECONDARY Complications Encountered During Procedure |
30; 24; 0; 0; 0; 0 | — |
| SECONDARY Passage of Device Through Sigmoid Colon |
17; 15 | — |
| SECONDARY Polyps Per Colonoscopy (PPC) |
2.71; 2.55 | — |
| SECONDARY Time Comparison for Each Method |
5.6; 5.7; 14.6; 14.9; 6.8; 6.9 | — |
| SECONDARY Cecal Intubation Rate |
294; 297 | — |
| SECONDARY Detection of Serrated Lesions |
40; 46; 122; 130 | — |
Summary
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.
Eligibility Criteria
Inclusion Criteria
- 40 years of age or older
- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- Able to provide written informed consent
Exclusion Criteria
- Active Inflammatory Bowel Disease
- Prior resection of the colon
- Referred for resection of a polyp identified by another physician
- Referred for a previous incomplete colonoscopy
Data sourced from ClinicalTrials.gov (NCT03560128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.