Colorectal CancerNCT05615857
Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
A study testing Use of Endocuff during colonoscopy in people with Colorectal Cancer and Colonic Polyps, run by Hopital Montfort at 1 site in Canada.
Trial summary
The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colonic Polyps
- What is being tested?
- Use of Endocuff during colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2022to 31 Jul 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing a colonoscopy during the study period
- Procedure being performed by a gastroenterologist (i.e., surgeons are excluded)
Who cannot join
- Inflammatory Bowel Disease
- Hereditary Mixed Polyposis Syndrome
- Diverticulitis
- Colonic stricture
- Toxic Megacolon
- Previous Colon surgery, excluding appendectomy
Show all 13Show fewer
- Radiation therapy to abdomen or pelvis
- Pregnancy/Lactation
- Anticoagulant use
- Suffered stroke or ischemia in previous 3 months
- Being deemed too risky by investigator
- FIT positive
- Poor preparation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.
Read the detailed description
Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?
- Conditions
- Colorectal Cancer, Colonic Polyps
- Being tested
- Use of Endocuff during colonoscopy
- Keywords
- Endocuff, Retroflexion, Colonoscopy, Polyp detection, Screening
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Endocuff during colonoscopyDevice
We will be adding the Endocuff device to the proximal end of the colonoscope, adding an additional tool to facilitate the visualization of the difficult-to-see mucosal areas as well as the rectum. There will be no need for retroflexion to evaluate the colon
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy without Endocuff | No intervention | No Endocuff inserted proximally to colonoscope and use of retroflexion |
| Colonoscopy with Endocuff | Experimental | Endocuff inserted proximally to colonoscope, no use of retroflexion Receives: Device: Use of Endocuff during colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy.
Measured: 1 hour
Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start22 Sep 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We are to count the number of adenomas and polyps identified per patient while using the Endocuff. These numbers will be compared to the number of identified adenomas and polyps found without the use of the Endocuff retrospectively. In addition, the number of adenomas and polyps found in the rectum while using the Endocuff will be compared to the numbers of adenomas and polyps found with retroflexion without the use of Endocuff. Once the colonoscopy is complete, the patient's level of comfort during the procedure will be documented.
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Sponsor
- Investigators
- Philip Hassard, MD, Principal investigator, Hopital MontfortChristine-Nadia Compas, CRC, Study director, Hopital Montfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615857
- Sponsor's protocol ID
- 22-23-04-002
- Status last verified
- Mar 2024
- First submitted
- 3 Oct 2022
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
- ClinicalTrials.gov ID
- NCT05615857
- Acronym / sponsor ID
- 22-23-04-002
- Conditions
- Colorectal Cancer, Colonic Polyps
- Keywords
- Endocuff, Retroflexion, Colonoscopy, Polyp detection, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 14 Nov 2022 (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 investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.
Detailed description
Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are to count the number of adenomas and polyps identified per patient while using the Endocuff. These numbers will be compared to the number of identified adenomas and polyps found without the use of the Endocuff retrospectively. In addition, the number of adenomas and polyps found in the rectum while using the Endocuff will be compared to the numbers of adenomas and polyps found with retroflexion without the use of Endocuff. Once the colonoscopy is complete, the patient's level of comfort during the procedure will be documented.
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy without Endocuff | No intervention | –No Endocuff inserted proximally to colonoscope and use of retroflexion |
| Colonoscopy with Endocuff | Experimental | Device: Use of Endocuff during colonoscopyEndocuff inserted proximally to colonoscope, no use of retroflexion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient undergoing a colonoscopy during the study period
- Procedure being performed by a gastroenterologist (i.e., surgeons are excluded)
Key exclusion criteria (13 listed)
- Inflammatory Bowel Disease
- Hereditary Mixed Polyposis Syndrome
- Diverticulitis
- Colonic stricture
- Toxic Megacolon
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 |
|---|---|---|
| Use of Endocuff during colonoscopyWe will be adding the Endocuff device to the proximal end of the colonoscope, adding an additional tool to facilitate the visualization of the difficult-to-see mucosal areas as well as the rectum. There will be no need for retroflexion to evaluate the colon | Device | Colonoscopy with Endocuff |
Primary outcome
Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
Time frame: 1 hour
Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy.
Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
Time frame: 1 hour
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.
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 12 Mar 2024.
- 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.
Philip Hassard, MD principal investigator
Hopital Montfort
Christine-Nadia Compas, CRC study director
Hopital Montfort
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Endocuff during colonoscopy in people with Colorectal Cancer and Colonic Polyps, run by Hopital Montfort 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 2 inclusion and 13 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 2024. 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?
Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy. (time frame: 1 hour). 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?
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 2024.