Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy

An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope

An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope

A standard colonoscope will be used to complete the procedure

colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

Colonoscopy with EndoCuff™

colonoscopy performed with the FUSE® (full spectrum endoscopy) system

FUSE® Colonoscopy

colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Colonoscopy with EndoRings™

Standard Colonoscopy

Douglas Rex, MD

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

Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

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

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

Number of patients with 1 or more sessile serrated polyps

Indiana University

Professor

A standard colonoscope will be used to complete the procedure

Standard Colonoscopy: Current standard of care colonoscopy

An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope

Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

Colonoscopy With EndoCuff™

An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope

Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Colonoscopy With EndoRings™

A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy

FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system

Total

Age, Continuous

Sex: Female, Male

White

Black or African American

Hispanic or Latino

Asian

Other

Unknown

Race/Ethnicity, Customized

Screening

Surveillance

Diagnostic

Indication

* Recruitment was uneven across the sites, and there were some differences between sites with regard to detection. Thus, some caution is appropriate in concluding generalizability.
* Endoscopists were not blinded to which device was in use.

Rachel Lahr

All Sites

Indianapolis

Milan

New York

The number of adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Adenomas Per Colonoscopy

The number of participants with detected adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Number of Participants With Detected Adenoma

The number of participants analyzed differed because the calculation was done for all three sites overall and then broken down into each specific site. Thus, only patients randomized to the treatment arm at that site were included in the specific site calculations instead of including the total number of patients randomized to that treatment arm.

Percentage of Participants With Detected Adenoma

The number of sessile serrated polyps per colonoscopy was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Sessile Serrated Polyps Per Colonoscopy

The number of participants with detected sessile serrated polyps was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Number of Participants With Detected Sessile Serrated Polyp

The number of participants analyzed for each site differed because the percentage of patients with a sessile serrated polyp was calculated specifically for the site. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.

Percentage of Participants With Detected Sessile Serrated Polyp

The number of participants with a detected polyp was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Number of Participants With a Detected Polyp

The number of participants analyzed for each site differed because the percentage of patients with a polyp was calculated for each site specifically. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.

Percentage of Participants With a Detected Polyp

The mean insertion time was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Cecal Insertion Time

Gastroenterology fellows were allowed to assist in inserting the scope, but times included in this analysis were from insertions done completely by the physician. This is why the overall number analyzed differs from the number analyzed in other outcome measure as well as why the numbers differ depending on site and randomization arm.

Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion

The mean inspection time of all three sites overall was calculated as well as the mean inspection time for each individual site. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy	NCT02345889	Colorectal Neop...	Colonoscopy wit... FUSE® Colonosco... Colonoscopy wit... Standard Colono...	50 Years -	Indiana University
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy	NCT02345889	Colorectal Neop...	Colonoscopy wit... FUSE® Colonosco... Colonoscopy wit... Standard Colono...	50 Years -	Indiana University

Spots Global Cancer Trial Database for colonoscopy with endorings™