N/A
N=200
Standard Colonoscopy Versus Colonoscopy With Endocuff Vision
Colorectal Polyp · Colorectal Adenoma · Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03361917 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) — 6.49; 8.42 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endocuff Vision (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) |
6.49; 8.42 | — |
| SECONDARY Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) |
4.05; 4.42 | — |
| SECONDARY Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) |
21.01; 21.24 | — |
| SECONDARY Detection Rates |
61.4; 52.5; 19.8; 11.1 | — |
| SECONDARY Polyps Per Colonoscopy |
1.43; 1.07; 0.27; 0.21 | — |
| SECONDARY Boston Bowel Preparation Score |
9; 9 | — |
Summary
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
Eligibility Criteria
Inclusion Criteria
- Subject referred for a screening or surveillance colonoscopy
- Subject is aged 40 years or older
- Subject has the ability to provide informed consent
Exclusion Criteria
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
- Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03361917). 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.