Colorectal PolypNCT03361917
Standard Colonoscopy Versus Colonoscopy With Endocuff Vision
A study testing Endocuff Vision in people with Colorectal Polyp and Colorectal Adenoma, run by Indiana University at 1 site in United States.
Trial summary
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Colorectal Adenoma, Colon Cancer
- What is being tested?
- Endocuff Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 18 Apr 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
- Subject referred for a screening or surveillance colonoscopy
- Subject is aged 40 years or older
- Subject has the ability to provide informed consent
Who cannot join
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
- Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
Read the detailed description
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.
- Conditions
- Colorectal Polyp, Colorectal Adenoma, Colon Cancer
- Being tested
- Endocuff Vision
- Keywords
- Colonoscopy screening, Colonscopy procedure
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff VisionDevice
Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Standard Colonscopy) | No intervention | Standard colonoscopy with no device attachments |
| Endocuff Vision | Experimental | Colonoscopy with Endocuff Vision attached to distal end of scope Receives: Device: Endocuff Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
Measured: During the withdrawal portion of the colonoscopy procedure
Secondary outcomes (5)
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
Measured: During the insertion portion of the colonoscopy procedure
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
Measured: During the colonoscopy procedure
Detection Rates
The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
Measured: During the colonoscopy procedure
Polyps Per Colonoscopy
Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
Measured: During the colonoscopy procedure
Boston Bowel Preparation Score
Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.
The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.
The quality of the bowel preparation is assessed by the attending gastroenterologist.
Measured: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start11 Dec 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 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 PolypStudies 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
- 200 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
- NCT03361917
- Sponsor's protocol ID
- 1709336500
- Status last verified
- Jul 2019
- First submitted
- 29 Nov 2017
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data can be shared in the future upon request.
Publications
Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13.
PubMed 28412271Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17.
PubMed 30659990
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times
- ClinicalTrials.gov ID
- NCT03361917
- Acronym / sponsor ID
- 1709336500
- Conditions
- Colorectal Polyp, Colorectal Adenoma, Colon Cancer
- Keywords
- Colonoscopy screening, Colonscopy procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 22 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
Detailed description
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.
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 Colonscopy) | No intervention | –Standard colonoscopy with no device attachments |
| Endocuff Vision | Experimental | Device: Endocuff VisionColonoscopy with Endocuff Vision attached to distal end of scope |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject referred for a screening or surveillance colonoscopy
- Subject is aged 40 years or older
- Subject has the ability to provide informed consent
Key exclusion criteria (7 listed)
- Prior history of colon cancer
- History of inflammatory bowel disease
- Prior surgical resection of any part of the colon
- Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
- History of polyposis syndrome or HNPCC
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 VisionSubjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. | Device | Endocuff Vision |
Primary outcome
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time frame: During the withdrawal portion of the colonoscopy procedure
Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
5 secondary outcomes
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time frame: During the insertion portion of the colonoscopy procedure
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time frame: During the colonoscopy procedure
Detection Rates
Time frame: During the colonoscopy procedure
Polyps Per Colonoscopy
Time frame: During the colonoscopy procedure
Boston Bowel Preparation Score
Time frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28412271Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13.
- Derived from this study: PubMed 30659990Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17.
- 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 in people with Colorectal Polyp and Colorectal Adenoma, 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 7 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 6 Aug 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 22 May 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?
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) (time frame: During the withdrawal portion of the 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 NCT03361917, 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 6 Aug 2019.