Colorectal AdenomaNCT03560128
Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
A study testing Endocuff Vision device and AmplifEYE device in people with Colorectal Adenoma and Colorectal Polyp, run by Indiana University at 1 site in United States.
Trial summary
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyp, Colorectal Cancer
- What is being tested?
- Endocuff Vision device and AmplifEYE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to 18 Dec 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.
Read the 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.
- Conditions
- Colorectal Adenoma, Colorectal Polyp, Colorectal Cancer
- Being tested
- Endocuff Vision device, AmplifEYE device
- Keywords
- 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.
Endocuff Vision deviceDevice
Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
AmplifEYE deviceDevice
Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endocuff Vision Arm | Experimental | Colonoscopy with Endocuff Vision device attached to the distal end of the scope. Receives: Device: Endocuff Vision device |
| AmplifEYE Arm | Experimental | Colonoscopy with AmplifEYE device attached to the distal end of the scope. Receives: Device: AmplifEYE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adenomas Detected Per Colonoscopy (APC).
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Measured: During colonoscopy procedure
Secondary outcomes (7)
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Measured: During colonoscopy procedure
Complications Encountered During Procedure
Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Measured: During Colonoscopy procedure
Passage of Device Through Sigmoid Colon
Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Measured: during insertion portion of colonoscopy
Polyps Per Colonoscopy (PPC)
Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Measured: During colonoscopy procedure
Time Comparison for Each Method
Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps.
Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps.
Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Measured: During colonoscopy procedure
Cecal Intubation Rate
Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Measured: During Colonoscopy procedure
Detection of Serrated Lesions
Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
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.
- First posted18 Jun 2018
- Study start12 Apr 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 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 (2)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
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas K Rex, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560128
- Sponsor's protocol ID
- 1802193017
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2018
- Last updated
- 8 Oct 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 can be shared in the future upon request.
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 29530353Rex 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.
PubMed 31319060
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.
- ClinicalTrials.gov ID
- NCT03560128
- Acronym / sponsor ID
- 1802193017
- Conditions
- Colorectal Adenoma, Colorectal Polyp, Colorectal Cancer
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 8 Oct 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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocuff Vision Arm | Experimental | Device: Endocuff Vision deviceColonoscopy with Endocuff Vision device attached to the distal end of the scope. |
| AmplifEYE Arm | Experimental | Device: AmplifEYE deviceColonoscopy with AmplifEYE device attached to the distal end of the scope. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age or older
- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Endocuff Vision deviceSubjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure. | Device | Endocuff Vision Arm |
| AmplifEYE deviceSubjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure. | Device | AmplifEYE Arm |
Primary outcome
Number of Adenomas Detected Per Colonoscopy (APC).
Time frame: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
7 secondary outcomes
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
Time frame: During colonoscopy procedure
Complications Encountered During Procedure
Time frame: During Colonoscopy procedure
Passage of Device Through Sigmoid Colon
Time frame: during insertion portion of colonoscopy
Polyps Per Colonoscopy (PPC)
Time frame: During colonoscopy procedure
Time Comparison for Each Method
Time frame: During colonoscopy procedure
Cecal Intubation Rate
Time frame: During Colonoscopy procedure
Detection of Serrated Lesions
Time frame: During colonoscopy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Derived from this study: PubMed 31319060Rex 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.
- Individual participant dataSharing planned: No. De-identified data can be shared in the future upon request.
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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 Endocuff Vision device and AmplifEYE 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 3 inclusion and 4 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 8 Oct 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 8 Oct 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?
Number of Adenomas Detected Per Colonoscopy (APC). (time frame: During colonoscopy 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 NCT03560128, which also lists 2 linked publications.
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 8 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.