Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate

Colonic Polyps Clinical Trial

Official title:

Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02885987
• Other study ID #: 5160326
• Status: Withdrawn
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: March 2022

Study information

• Verified date: October 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.

Exclusion Criteria:

• Any pregnant patient

• Patient's that are unable to provide consent for themselves

• Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)

• Any patient undergoing surveillance (prior history of polyps or colorectal cancer)

• Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member <65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)

• Prior history of any cancer

• Current or past immunosuppression (due to either infection or medications)

• Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure

• Colonic strictures

• suspected intestinal obstruction or colonic pseudo-obstruction

• history of colon resection

• active infection

• active inflammation (including diverticulitis)

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyps

Intervention

Device:
• AmplifEYE
AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.	ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed.	1 week
Secondary	ADR will be differentiated according to morphology	ADR will be differentiated according to morphology (flat, sessile, pedunculated)	1 week
Secondary	ADR will be differentiated according to final pathology	ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)	1 week
Secondary	ADR will be differentiated according to location	Location will be specified by colon segment and flexures.	1 week
Secondary	Advanced ADR	calculated as same for ADR, but only in those with polyps that are >=1 cm in size, with components of villous features, or with those of dysplasia	1 week
Secondary	Mean total number of polyps detected	calculated by dividing the total number of adenomas detected by the total number of screening procedures performed	1 week
Secondary	ADR-plus	mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected	1 week
Secondary	APP (adenomas per positive participant)	calculated as the total number of adenomas detected during the first colonoscopy divided by the number of positive participants (those with =1 adenoma detected during the first colonoscopy)	1 week
Secondary	APC (adenomas per colonoscopy)	calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies	1 week
Secondary	Quality metrics: time of colonoscopy	Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.	1 hour
Secondary	Quality metrics: prep quality	Differences in prep quality will be noted	1 hour
Secondary	Sedative Medications used	Differences in sedative medications used	1 hour