N/A Completed N=1,262 Randomized Single-blind Screening

A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Colorectal Cancer

Source: ClinicalTrials.gov NCT02345889 ↗

Enrolled (actual)

1,262

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcomePrimary: Adenomas Per Colonoscopy — 1.53; 1.82; 1.55; 1.30 Adenomas per Colonoscopy

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.