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N/A N=126 Randomized Single-blind Prevention

Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments

Colon Cancer Screening · Colon Polyps · Colon Adenomas · Water Exchange Colonoscopy

Bottom Line

View on ClinicalTrials.gov: NCT02665741 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Adenoma Detection Rate — 52.4; 40.5; 54.8 percentage of adenomas detected

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Olympus transparent cap (Device); Medivators Endocuff (Device); Control (Device)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
University of California, Davis
Primary completion
Feb 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Adenoma Detection Rate		 52.4; 40.5; 54.8 —
SECONDARY
Proximal Adenoma Detection Rate		 45.2; 35.7; 50.0 —
SECONDARY
Cecal Intubation Rate		 100; 100; 100 —
SECONDARY
Withdrawal Time		 12.9; 12.4; 13.0 —

Summary

The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.

Eligibility Criteria

Inclusion Criteria

  • At least 50 years old
  • Presenting for a screening or surveillance colonoscopy at UC Davis Endoscopy Suites

Exclusion Criteria

  • Age less than 50 years
  • Prior history of colon cancer
  • Patients with inflammatory bowel disease
  • Patients suspected to have colon cancer based on non invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
  • Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc, or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
  • Patients with family history of colon cancer in 1st degree relative below the age of 60
  • Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc, which are associated with an increased risk of colon cancer
  • Patients unable to consent
  • Pregnant patients
  • Incarcerated patients
  • Non-English speakers
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02665741). 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.

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