Colorectal AdenomaNCT03418662

EndoRings Colonoscopy vs Standard Colonoscopy

A study testing EndoRings device in people with Colorectal Adenoma and Colorectal Polyp, 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

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Colorectal Adenoma, Colorectal Polyp, Colon Cancer
What is being tested?: EndoRings device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 592 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2018to 13 Sep 2018
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Screening or Surveillance Colonoscopy
Able to provide written informed consent

Who cannot join

Known narrow colon or colon stenosis
Personal history of Colorectal cancer
History of inflammatory bowel disease
Familial adenomatous polyposis syndrome (FAP)
Hyperplastic polyposis syndrome
Referral for incomplete colonoscopy or polyp clearance

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Read the detailed description

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Conditions: Colorectal Adenoma, Colorectal Polyp, Colon Cancer
Being tested: EndoRings device
Keywords: Colonoscopy
Medical subject headings: Colonic Neoplasms

What participants receive

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

EndoRings deviceDevice
Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.

Study groups in NCT03418662
Study group	Role	What they receive
Control Arm (Standard Colonoscopy)	No intervention	Standard colonoscopy with no device attachment.
EndoRings Colonoscopy	Experimental	Colonoscopy with EndoRings device attached to the distal end of the scope. Receives: Device: EndoRings device

What is being measured

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

Adenoma Detection Rates
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Measured: During colonoscopy procedure
Number of Adenomas Per Colonoscopy
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
Measured: During colonoscopy procedure

Secondary outcomes (7)

Polyp Detection Rate
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
Measured: During colonoscopy procedure
Number of Detections Per Colonoscopy
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
Measured: During colonoscopy procedure
Total Number of Detections
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
Measured: During colonoscopy procedure
Cecal Intubation Rate
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
Measured: During colonoscopy procedure
Time Comparison for Each Method
Comparison of the time required to reach the cecum, withdrawal time, and total procedure time.
Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps.
Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
Measured: During colonoscopy procedure
Patient Comfort Score
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
Measured: After colonoscopy was completed while patient was in recovery area of endoscopy unit
Problems Encountered With Equipment
Occurrences of slippage of EndoRings or of device being removed on insertion.
Measured: During colonoscopy procedure

Timeline

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

19 Jan 201813 Sep 2018

First posted1 Feb 2018
Study start19 Jan 2018
Primary completion13 Sep 2018
Study completion13 Sep 2018

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 AdenomaStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 592 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03418662
Sponsor's protocol ID: 1711224972
Status last verified: Sep 2019
First submitted: 2 Jan 2018
Last updated: 20 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: De-identified data may be shared upon the discretion of the principal investigator.

Publications

Rex DK, Kessler WR, Sagi SV, Rogers NA, Fischer M, Bohm ME, Wo JM, Dewitt JM, McHenry L, Lahr RE, Searight MP, MacPhail M, Sullivan AW, McWhinney CD, Vemulapalli KC. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial. Gastrointest Endosc. 2020 Jan;91(1):115-120. doi: 10.1016/j.gie.2019.06.042. Epub 2019 Jul 9.
PubMed 31299257

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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All Colorectal Adenoma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).
ClinicalTrials.gov ID: NCT03418662
Acronym / sponsor ID: 1711224972
Conditions: Colorectal Adenoma, Colorectal Polyp, Colon Cancer
Keywords: Colonoscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 592 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: US Endoscopy
Study start: 19 Jan 2018 (actual)
Primary completion: 13 Sep 2018 (actual)
Study completion: 13 Sep 2018 (actual)
First posted: 1 Feb 2018 (actual)
Results: Posted 20 Sep 2019

Clinical summary

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

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Arm (Standard Colonoscopy)	No intervention	–Standard colonoscopy with no device attachment.
EndoRings Colonoscopy	Experimental	Device: EndoRings deviceColonoscopy with EndoRings device attached to the distal end of the scope.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Screening or Surveillance Colonoscopy
Able to provide written informed consent

Key exclusion criteria (6 listed)

Known narrow colon or colon stenosis
Personal history of Colorectal cancer
History of inflammatory bowel disease
Familial adenomatous polyposis syndrome (FAP)
Hyperplastic polyposis syndrome

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
EndoRings deviceSubjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Device	EndoRings Colonoscopy

Primary outcome

Adenoma Detection Rates
Time frame: During colonoscopy procedure
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
Number of Adenomas Per Colonoscopy
Time frame: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

7 secondary outcomes

Polyp Detection Rate
Time frame: During colonoscopy procedure
Number of Detections Per Colonoscopy
Time frame: During colonoscopy procedure
Total Number of Detections
Time frame: During colonoscopy procedure
Cecal Intubation Rate
Time frame: During colonoscopy procedure
Time Comparison for Each Method
Time frame: During colonoscopy procedure
Patient Comfort Score
Time frame: After colonoscopy was completed while patient was in recovery area of endoscopy unit
Problems Encountered With Equipment
Time frame: During colonoscopy procedure

Results and safety

Results posted to the registry on 20 Sep 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
EndoRings Colonoscopy	287	284
Control Arm (Standard Colonoscopy)	282	278

Primary outcome: Adenoma Detection Rates

Time frame: During colonoscopy procedure. Count of participants. Unit: Participants

Measure	EndoRings Colonoscopy n = 284	Control Arm (Standard Colonoscopy) n = 278
Value	143	124

Primary outcome: Number of Adenomas Per Colonoscopy

Time frame: During colonoscopy procedure. Mean (Standard Deviation). Unit: adenomas per colonoscopy

Measure	EndoRings Colonoscopy n = 284	Control Arm (Standard Colonoscopy) n = 278
Value	1.46 (2.69)	1.06 (1.83)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the colonoscopy procedure and while the patient was in the recovery section of the endoscopy suite immediately after the procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EndoRings Colonoscopy	0 of 284 (0%)	0 of 284 (0%)	0 of 284
Control Arm (Standard Colonoscopy)	0 of 278 (0%)	0 of 278 (0%)	0 of 278

Limitations and caveats (from the sponsor): Single center design; Inability to blind endoscopists to device randomization; Most patients were sedated with propofol so it would not reasonably be expected to have a difference in patient comfort score

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31299257Rex DK, Kessler WR, Sagi SV, Rogers NA, Fischer M, Bohm ME, Wo JM, Dewitt JM, McHenry L, Lahr RE, Searight MP, MacPhail M, Sullivan AW, McWhinney CD, Vemulapalli KC. Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial. Gastrointest Endosc. 2020 Jan;91(1):115-120. doi: 10.1016/j.gie.2019.06.042. Epub 2019 Jul 9.
Individual participant dataSharing planned: No. De-identified data may be shared upon the discretion of the principal investigator.

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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 K 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 EndoRings device in people with Colorectal Adenoma and Colorectal Polyp, 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 2 inclusion and 6 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 20 Sep 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 20 Sep 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?

Adenoma Detection Rates (time frame: During colonoscopy procedure). The study lists 2 primary outcomes in all. 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 NCT03418662, 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 20 Sep 2019.