N/A
N=1,262
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02345889 ↗Enrolled (actual)
1,262
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Adenomas Per Colonoscopy — 1.53; 1.82; 1.55; 1.30 Adenomas per Colonoscopy
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colonoscopy with EndoCuff™ (Device); FUSE® Colonoscopy (Device); Colonoscopy with EndoRings™ (Device); Standard Colonoscopy (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenomas Per Colonoscopy |
1.53; 1.82; 1.55; 1.30; 1.89; 2.17 | — |
| SECONDARY Number of Participants With Detected Adenoma |
166; 191; 167; 154; 117; 137 | — |
| SECONDARY Percentage of Participants With Detected Adenoma |
56; 64; 57; 52; 61; 70 | — |
| SECONDARY Sessile Serrated Polyps Per Colonoscopy |
0.17; 0.17; 0.20; 0.18; 0.24; 0.23 | — |
| SECONDARY Number of Participants With Detected Sessile Serrated Polyp |
36; 33; 33; 30; 33; 29 | — |
| SECONDARY Percentage of Participants With Detected Sessile Serrated Polyp |
12; 11; 11; 10; 17; 15 | — |
| SECONDARY Number of Participants With a Detected Polyp |
226; 247; 231; 212; 162; 175 | — |
| SECONDARY Percentage of Participants With a Detected Polyp |
77; 83; 78; 71; 84; 89 | — |
| SECONDARY Cecal Insertion Time |
422; 354; 403; 468; 366; 320 | — |
| SECONDARY Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion |
320; 265; 331; 380; 283; 239 | — |
| SECONDARY Inspection Time |
444; 419; 417; 421; 418; 392 | — |
| SECONDARY Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |
205; 253; 213; 194; 160; 199 | — |
| SECONDARY Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |
78; 79; 76; 75; 14; 15 | — |
| SECONDARY Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |
20; 32; 29; 25; 9; 11 | — |
| SECONDARY Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |
45; 34; 28; 36; 30; 31 | — |
Summary
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
Eligibility Criteria
Inclusion Criteria
- Screening or Surveillance Colonoscopy
Exclusion Criteria
- Personal history of Colorectal cancer or Inflammatory bowel disease
- Surgical resection of the colon or known colonic stricture
- Personal or family history of Polyposis syndromes or Lynch syndrome
- Referral for incomplete colonoscopy or known therapeutic polyp clearance
- Severe diverticular disease
- Referral for a positive hemoccult test in the past 6 months
- Known coagulopathy
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT02345889). 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.