Clinical trial NCT03560128: Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
Official title: Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Polyp
Colorectal Cancer
Keywords: Colonoscopy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 634
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Detailed description: This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Eligibility criteria: Inclusion Criteria:

* 40 years of age or older
* Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
* Able to provide written informed consent

Exclusion Criteria:

* Active Inflammatory Bowel Disease
* Prior resection of the colon
* Referred for resection of a polyp identified by another physician
* Referred for a previous incomplete colonoscopy

Primary outcomes:
measure: Number of Adenomas Detected Per Colonoscopy (APC).
timeFrame: During colonoscopy procedure
Secondary outcomes:
measure: Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
timeFrame: During colonoscopy procedure
measure: Complications Encountered During Procedure
timeFrame: During Colonoscopy procedure
measure: Passage of Device Through Sigmoid Colon
timeFrame: during insertion portion of colonoscopy
measure: Polyps Per Colonoscopy (PPC)
timeFrame: During colonoscopy procedure
measure: Time Comparison for Each Method
timeFrame: During colonoscopy procedure
measure: Cecal Intubation Rate
timeFrame: During Colonoscopy procedure
measure: Detection of Serrated Lesions
timeFrame: During colonoscopy procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9.
citation: Rex DK, Sagi SV, Kessler WR, Rogers NA, Fischer M, Bohm ME, Dewitt JM, Lahr RE, Searight MP, Sullivan AW, McWhinney CD, Garcia JR, Broadley HM, Vemulapalli KC. A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial. Gastrointest Endosc. 2019 Nov;90(5):835-840.e1. doi: 10.1016/j.gie.2019.06.046. Epub 2019 Jul 15.