Colorectal NeoplasmsNCT02345889

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

A study testing Colonoscopy with EndoCuff™, FUSE® Colonoscopy and Colonoscopy with EndoRings™ in people with Colorectal Neoplasms, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Colorectal Neoplasms
What is being tested?: Colonoscopy with EndoCuff™, FUSE® Colonoscopy and Colonoscopy with EndoRings™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,262 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Screening or Surveillance Colonoscopy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Hospital
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: Colorectal Neoplasms
Being tested: Colonoscopy with EndoCuff™, FUSE® Colonoscopy, Colonoscopy with EndoRings™, Standard Colonoscopy
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colonoscopy with EndoCuff™Device
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
FUSE® ColonoscopyDevice
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
Colonoscopy with EndoRings™Device
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
Standard ColonoscopyDevice
Current standard of care colonoscopy

Study groups in NCT02345889
Study group	Role	What they receive
FUSE® Colonoscopy	Active comparator	A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy Receives: Device: FUSE® Colonoscopy
Colonoscopy with EndoCuff™	Active comparator	An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope Receives: Device: Colonoscopy with EndoCuff™
Colonoscopy with EndoRings™	Active comparator	An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope Receives: Device: Colonoscopy with EndoRings™
Standard Colonoscopy	Active comparator	A standard colonoscope will be used to complete the procedure Receives: Device: Standard Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Adenomas Per Colonoscopy
Measured: During Procedure

Secondary outcomes (14)

Number of Participants With Detected Adenoma
Measured: During Procedure
Percentage of Participants With Detected Adenoma
Measured: During Procedure
Sessile Serrated Polyps Per Colonoscopy
Measured: During Procedure
Number of Participants With Detected Sessile Serrated Polyp
Number of patients with 1 or more sessile serrated polyps
Measured: During Procedure
Percentage of Participants With Detected Sessile Serrated Polyp
Measured: During Procedure
Number of Participants With a Detected Polyp
Measured: During Procedure
Percentage of Participants With a Detected Polyp
Measured: During Procedure
Cecal Insertion Time
Measured: During Procedure
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Measured: During Procedure
Inspection Time
Measured: During Procedure
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Measured: During Procedure
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Measured: During Procedure
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Measured: During Procedure
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Measured: During Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Dec 2017

First posted26 Jan 2015 (estimated)
Study startFeb 2015
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02345889
Sponsor's protocol ID: 1412036333
Status last verified: Feb 2019
First submitted: 13 Jan 2015
Last updated: 12 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29530353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
ClinicalTrials.gov ID: NCT02345889
Acronym / sponsor ID: 1412036333
Conditions: Colorectal Neoplasms
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,262 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Feb 2015 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 26 Jan 2015 (estimated)
Results: Posted 12 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
FUSE® Colonoscopy	Active comparator	Device: FUSE® ColonoscopyA FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
Colonoscopy with EndoCuff™	Active comparator	Device: Colonoscopy with EndoCuff™An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™	Active comparator	Device: Colonoscopy with EndoRings™An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Standard Colonoscopy	Active comparator	Device: Standard ColonoscopyA standard colonoscope will be used to complete the procedure

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Screening or Surveillance Colonoscopy

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colonoscopy with EndoCuff™colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope	Device	Colonoscopy with EndoCuff™
FUSE® Colonoscopycolonoscopy performed with the FUSE® (full spectrum endoscopy) system	Device	FUSE® Colonoscopy
Colonoscopy with EndoRings™colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope	Device	Colonoscopy with EndoRings™
Standard ColonoscopyCurrent standard of care colonoscopy	Device	Standard Colonoscopy

Primary outcome

Adenomas Per Colonoscopy
Time frame: During Procedure

14 secondary outcomes

Number of Participants With Detected Adenoma
Time frame: During Procedure
Percentage of Participants With Detected Adenoma
Time frame: During Procedure
Sessile Serrated Polyps Per Colonoscopy
Time frame: During Procedure
Number of Participants With Detected Sessile Serrated Polyp
Time frame: During Procedure
Percentage of Participants With Detected Sessile Serrated Polyp
Time frame: During Procedure
Number of Participants With a Detected Polyp
Time frame: During Procedure
Percentage of Participants With a Detected Polyp
Time frame: During Procedure
Cecal Insertion Time
Time frame: During Procedure
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Time frame: During Procedure
Inspection Time
Time frame: During Procedure
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure

Results and safety

Results posted to the registry on 12 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Colonoscopy	316	295
Colonoscopy With EndoCuff™	316	299
Colonoscopy With EndoRings™	315	295
FUSE® Colonoscopy	315	299

Primary outcome: Adenomas Per Colonoscopy

Time frame: During Procedure. Mean (Standard Deviation). Unit: Adenomas per Colonoscopy

Measure	Standard Colonoscopy n = 295	Colonoscopy With EndoCuff™ n = 299	Colonoscopy With EndoRings™ n = 295	FUSE® Colonoscopy n = 299
All Sites	1.53 (2.33)	1.82 (2.58)	1.55 (2.42)	1.30 (1.96)
Indianapolis	1.89 (2.69)	2.17 (2.88)	1.97 (2.77)	1.59 (2.18)
Milan	0.83 (1.18)	0.80 (1.25)	0.72 (1.17)	0.68 (1.19)
New York	0.92 (1.15)	2.00 (2.34)	0.75 (0.94)	0.80 (1.32)

Population analysed: 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.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Colonoscopy	0 of 295 (0%)	0 of 295 (0%)	0 of 295
Colonoscopy With EndoCuff™	0 of 299 (0%)	0 of 299 (0%)	0 of 299
Colonoscopy With EndoRings™	0 of 295 (0%)	0 of 295 (0%)	0 of 295
FUSE® Colonoscopy	0 of 299 (0%)	0 of 299 (0%)	0 of 299

Limitations and caveats (from the sponsor): * 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29530353Rex 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Rex, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colonoscopy with EndoCuff™, FUSE® Colonoscopy and Colonoscopy with EndoRings™ in people with Colorectal Neoplasms, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenomas Per Colonoscopy (time frame: During Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02345889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.