N/A
N=194
Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03807089 ↗Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Patients With At Least One Adenoma — 63; 68 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional Pediatric Colonoscope (Device); Short-Turn Radius Colonoscope (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With At Least One Adenoma |
63; 68 | — |
| SECONDARY Overall Polyp Detection Rate |
72; 78 | — |
| SECONDARY Mean Number of Adenomas Identified Per Patient With Polyps |
2.48; 2.50 | — |
Summary
The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.
Eligibility Criteria
Inclusion Criteria
- Ability to provide Informed Consent
- Age > 40
- Surveillance Colonoscopy (History of Adenomas)
Exclusion Criteria
- Poor or Fair Bowel Prep
- Difficult First Insertion
- Familial Polyposis
- Inflammatory Bowel Disease
- Pregnancy
- Active GI Bleeding
- Prior colonic or rectal resection
- Conserved Sattus
- Colonoscopy less than 3 years ago
- Screening Colonoscopy
- Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits
Data sourced from ClinicalTrials.gov (NCT03807089). 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.