Colorectal NeoplasmsNCT04395352
Effectiveness of Endocuff Vision in Improving ADR
An observational study of Colorectal Neoplasms, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Endocuff Vision (ECV)
- Type of treatment
- Medical device
- How many people
- 15,816 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing screening-related colonoscopy.
Who may be able to join
- adult patients undergoing colonoscopy.
Who cannot join
- single balloon- or double balloon-assisted colonoscopy;
- planned advanced polypectomy or endoscopic mucosal resection (EMR);
- planned endoscopic post-polypectomy or post-EMR surveillance;
- known active diverticulitis;
- known colonic stricture.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Forzani and MacPhail Colon Cancer Screening Centre (CCSC)
Calgary, Alberta, T2N 4Z6
About this study
Official title: Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort
The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.
- Conditions
- Colorectal Neoplasms
- Being tested
- Endocuff Vision (ECV)
- 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 (ECV)Device
Detachable disposable (single-use) device that fits over the distal colonoscope end.
| Study group | Role | What they receive |
|---|---|---|
| Pre-ECV | Patients having undergone colonoscopy prior to the introduction of ECV (November 1 2018 to April 30 2019). | |
| ECV | Patients having undergone colonoscopy after the introduction of ECV (June 1 2019 to November 30 2019). Receives: Device: Endocuff Vision (ECV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed
Measured: Intra-procedural
Secondary outcomes (7)
Adenoma detection rate among patients with positive fecal immunochemical tests
Proportion of an endoscopist's colonoscopies performed for +fecal immunochemical test (FIT), or indications other than positive FIT during which one or more adenoma was biopsied or removed. In order to be included in the non-FIT ADR category, a patient must not have undergone a colonoscopy at CCSC within the last four years of the index procedure.
Measured: Intra-procedural
SSADR (sessile serrated adenoma detection rate)
Proportion of an endoscopist's screening-related colonoscopies during which one or more sessile serrated adenoma was biopsied or removed
Measured: Intra-procedural
CIR (cecal intubation rate)
Proportion of an endoscopist's screening-related procedures in which the cecal pole is intubated, as landmarked by direct visualization of the appendiceal orifice, ileocecal valve, or both.
Measured: Intra-procedural
Procedure time
Total time spent by an endoscopist from the start of the colonoscopy procedure (insertion of the colonoscope through the anus) to the end of the colonoscopy (removal of the colonoscope from the anus). This variable will be calculated only for cases in which no pathology was encountered.
Measured: Intra-procedural
Nurse-assessed patient comfort scores (NAPCOMs)
Validated score for determining patients' procedural comfort. Scored from 0 to 9, with higher scores indicating higher discomfort intensity, frequency, and/or duration.
Measured: Intra-procedural
Number of patients with immediate adverse events
Adverse events occurring at the time of colonoscopy or before discharge, including bleeding or perforation.
Measured: Day 1
Number of patients with delayed adverse events
Adverse events within 30 days of the index procedure, including delayed bleeding, delayed perforation, or acute healthcare utilization (emergency department visit or hospital admission) for any other reasons deemed related to index colonoscopy.
Measured: Within 30 days of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Nov 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15,816 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395352
- Sponsor's protocol ID
- HREBA.CC-19-0257
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort
- ClinicalTrials.gov ID
- NCT04395352
- Acronym / sponsor ID
- HREBA.CC-19-0257
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,816 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-ECV | – | –Patients having undergone colonoscopy prior to the introduction of ECV (November 1 2018 to April 30 2019). |
| ECV | – | Device: Endocuff Vision (ECV)Patients having undergone colonoscopy after the introduction of ECV (June 1 2019 to November 30 2019). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing screening-related colonoscopy.
Key inclusion criteria (1 listed)
- adult patients undergoing colonoscopy.
Key exclusion criteria (5 listed)
- single balloon- or double balloon-assisted colonoscopy;
- planned advanced polypectomy or endoscopic mucosal resection (EMR);
- planned endoscopic post-polypectomy or post-EMR surveillance;
- known active diverticulitis;
- known colonic stricture.
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 (ECV)Detachable disposable (single-use) device that fits over the distal colonoscope end. | Device | ECV |
Primary outcome
Adenoma detection rate (ADR)
Time frame: Intra-procedural
Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed
7 secondary outcomes
Adenoma detection rate among patients with positive fecal immunochemical tests
Time frame: Intra-procedural
SSADR (sessile serrated adenoma detection rate)
Time frame: Intra-procedural
CIR (cecal intubation rate)
Time frame: Intra-procedural
Procedure time
Time frame: Intra-procedural
Nurse-assessed patient comfort scores (NAPCOMs)
Time frame: Intra-procedural
Number of patients with immediate adverse events
Time frame: Day 1
Number of patients with delayed adverse events
Time frame: Within 30 days of index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by University of Calgary at 1 site in Canada.
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 5 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 May 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate (ADR) (time frame: Intra-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.