N/A
Completed N=84
High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study
Colonic Polyps
Source: ClinicalTrials.gov NCT01761279 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Diagnostic Accuracy of In-vivo Polyp Assessment — 93.3; 94.7 % diagnostic accuracy
Summary
Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).
Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.
i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.
Hypothesis:
High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy of In-vivo Polyp Assessment |
93.3; 94.7 | — |
| SECONDARY Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size |
95.5; 97.0 | — |
| SECONDARY Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size |
89.3; 90.7 | — |
| SECONDARY Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size |
100; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Patients found to have colonic polyps up to 10mm in size
Exclusion Criteria
- Poor bowel preparation
- Inflammatory bowel disease
- Polyposis syndrome
Data sourced from ClinicalTrials.gov (NCT01761279). 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. Informational only — not medical advice.