Cancer ColorectalNCT04280393
Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening
A study testing Colonoscopy procedure with endocuff in people with Cancer Colorectal, run by Hospital Provincial de Castellon at 1 site in Spain.
Trial summary
The hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Colonoscopy procedure with endocuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 30 Nov 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program.
- With the ability to provide informed consent
Who cannot join
- History of inflammatory bowel disease
- History or suspected obstruction or intestinal pseudo-obstruction located in the colon
- History of colon cancer or polyposic syndromes
- History of colonic stenosis
- History of severe diverticular segments in some region of the colon
- Subjects unable to provide informed consent
Show all 12Show fewer
- Subjects under treatment with clopidogrel, warfarin, acenocoumarol or other new generation anticoagulants that have not discontinued treatment in accordance with the provisions of these procedures
- Pregnants females
- Subjects who are going to undergo a therapeutic or surveillance endoscopy for follow-up of injuries diagnosed in previous procedures
- Subjects whose baseline status does not allow the completion of the questionnaires necessary for the evaluation of the study objectives.
- History of previous colonic surgery except for appendectomy
- Any medical, psychological, psychiatric, geographic or social problem that is important and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness And Safety Of The Colonoscopy Assisted By Endocuff Visio Vs. Standard Colonoscopy In The Colorectal Cancer Screening Program: Clinical Random, Prospective, Multicentric, Open And Parallel Groups
The hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
Read the detailed description
The main objective of the colorectal cancer screening program (CRC) is the detection of the greatest number of precursor lesions of neoplasms as well as cancerous lesions established in the general population with an intermediate risk of presenting CRC. Within this program, colonoscopy is considered the diagnostic technique of choice due to its cost-effectiveness balance. However, it remains a technique that is not entirely perfect since the omission of injuries during the procedure constitutes the main reason for the appearance of interval cancers, with a clear correlation between the rate of detection of adenomas and their appearance.
The vast majority of CRC arise from precancerous polyps, of which there are two main types: conventional adenomas and serrated polyps. Conventional adenomas are the most frequent polyps being responsible for the majority of CRC through the adenoma-carcinoma sequence. It should be taken into account that about 15-30% of sporadic CRC develops from serrated polyps through the serrated pathway of carcinogenesis, which is different from the traditional adenoma-carcinoma sequence. Endoscopic detection of serrated polyps is difficult due to their indistinguishable edges and flat or sessile morphology. In addition, they tend to be located in the right colon, a place that can be more difficult to reach in colonoscopy and examine completely.
Therefore, the ultimate goal of CRC screening colonoscopy is to reduce the appearance of CRC, trying to maximize the detection of polyps and therefore the detection rate of adenomas. For this there are several technical factors of colonoscopy, preparation, imaging and external devices that try to achieve an increase in the rate of detection of adenomas.
ENDOCUFF VISION® (Norgine Pharmaceuticals Ltd) is a medical device that is fixed at the distal end of the endoscope, improving its insertion in the intestine thanks to the action it exerts by flattening the folds and stabilizing the device. Its use is related to greater accuracy in the detection of adenomas, since it increases the visibility of the mucosa and thus decreases the number of polyps that may go unnoticed, increasing the detection rate of adenomas between 10 and 16 percentage points, according with published literature .
Thus, the hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
- Conditions
- Cancer Colorectal
- Being tested
- Colonoscopy procedure with endocuff
- Keywords
- adenoma, colonoscopy, endocuff, screening
- Medical subject headings
- Colonic Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy procedure with endocuffDevice
Colonoscopy procedure with the use of ENDOCUFF VISION
| Study group | Role | What they receive |
|---|---|---|
| Endocuff | Experimental | Colonoscopy procedure with the use of endocuff Receives: Device: Colonoscopy procedure with endocuff |
| Control | Active comparator | Standard Colonoscopy procedure Receives: Device: Colonoscopy procedure with endocuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
polyps detection rate per patient
Rate of polyps detected
Measured: immediately after the procedure
adenoma detection rate per patient
Rate of Adenoma detected
Measured: immediately after the procedure
Secondary outcomes (7)
differences in the mean of adenomas detected by patient
Assess whether there are differences in the mean of adenomas detected by patient comparing Endocuff Colonoscopy and Standard Colonoscopy.
Measured: immediately after the procedure
Serrated adenoma rate detected by patient
Rate of serrated adenomas
Measured: immediately after the procedure
Cancer lesion detection rate comparing Endocuff Colonoscopy and Standard Colonoscopy.
Rate of lessions
Measured: immediately after the procedure
Cecal intubation rate and time to reach the cecum
Time in minutes of the intubation
Measured: immediately after the procedure
Total time of the procedure
Total time of the procedure, from the insertion of the colonoscope to its extraction comparing Endocuff Colonoscopy and Standard Colonoscopy.
Measured: immediately after the procedure
Colonoscope withdrawal time from cecum
Colonoscope withdrawal time from cecum in patients in whom no polyps were detected
Measured: immediately after the procedure
Demonstrate the non-inferiority of patient experience when comparing Endocuff Colonoscopy and Standard Colonoscopy
Number of Participants With Procedure-Related Adverse Events Intra and post-procedure (evaluated with CTC AE v4) comparing Endocuff Colonoscopy and Standard Colonoscopy. This will be calculated as a Rate of Intra and post-procedure complications.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start10 Feb 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies 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
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Provincial de Castellon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Sabado Marti, Hospital Provincial de Castellon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280393
- Sponsor's protocol ID
- FCVHPC-2018-PS-01
- Status last verified
- Nov 2022
- First submitted
- 14 Feb 2020
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness And Safety Of The Colonoscopy Assisted By Endocuff Visio Vs. Standard Colonoscopy In The Colorectal Cancer Screening Program: Clinical Random, Prospective, Multicentric, Open And Parallel Groups
- ClinicalTrials.gov ID
- NCT04280393
- Acronym / sponsor ID
- FCVHPC-2018-PS-01
- Conditions
- Cancer Colorectal
- Keywords
- adenoma, colonoscopy, endocuff, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- Hospital Provincial de CastellonUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Feb 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 hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
Detailed description
The main objective of the colorectal cancer screening program (CRC) is the detection of the greatest number of precursor lesions of neoplasms as well as cancerous lesions established in the general population with an intermediate risk of presenting CRC. Within this program, colonoscopy is considered the diagnostic technique of choice due to its cost-effectiveness balance. However, it remains a technique that is not entirely perfect since the omission of injuries during the procedure constitutes the main reason for the appearance of interval cancers, with a clear correlation between the rate of detection of adenomas and their appearance.
The vast majority of CRC arise from precancerous polyps, of which there are two main types: conventional adenomas and serrated polyps. Conventional adenomas are the most frequent polyps being responsible for the majority of CRC through the adenoma-carcinoma sequence. It should be taken into account that about 15-30% of sporadic CRC develops from serrated polyps through the serrated pathway of carcinogenesis, which is different from the traditional adenoma-carcinoma sequence. Endoscopic detection of serrated polyps is difficult due to their indistinguishable edges and flat or sessile morphology. In addition, they tend to be located in the right colon, a place that can be more difficult to reach in colonoscopy and examine completely.
Therefore, the ultimate goal of CRC screening colonoscopy is to reduce the appearance of CRC, trying to maximize the detection of polyps and therefore the detection rate of adenomas. For this there are several technical factors of colonoscopy, preparation, imaging and external devices that try to achieve an increase in the rate of detection of adenomas.
ENDOCUFF VISION® (Norgine Pharmaceuticals Ltd) is a medical device that is fixed at the distal end of the endoscope, improving its insertion in the intestine thanks to the action it exerts by flattening the folds and stabilizing the device. Its use is related to greater accuracy in the detection of adenomas, since it increases the visibility of the mucosa and thus decreases the number of polyps that may go unnoticed, increasing the detection rate of adenomas between 10 and 16 percentage points, according with published literature .
Thus, the hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocuff | Experimental | Device: Colonoscopy procedure with endocuffColonoscopy procedure with the use of endocuff |
| Control | Active comparator | Device: Colonoscopy procedure with endocuffStandard Colonoscopy procedure |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program.
- With the ability to provide informed consent
Key exclusion criteria (12 listed)
- History of inflammatory bowel disease
- History or suspected obstruction or intestinal pseudo-obstruction located in the colon
- History of colon cancer or polyposic syndromes
- History of colonic stenosis
- History of severe diverticular segments in some region of the colon
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 |
|---|---|---|
| Colonoscopy procedure with endocuffColonoscopy procedure with the use of ENDOCUFF VISION | Device | Control, Endocuff |
Primary outcome
polyps detection rate per patient
Time frame: immediately after the procedure
Rate of polyps detected
adenoma detection rate per patient
Time frame: immediately after the procedure
Rate of Adenoma detected
7 secondary outcomes
differences in the mean of adenomas detected by patient
Time frame: immediately after the procedure
Serrated adenoma rate detected by patient
Time frame: immediately after the procedure
Cancer lesion detection rate comparing Endocuff Colonoscopy and Standard Colonoscopy.
Time frame: immediately after the procedure
Cecal intubation rate and time to reach the cecum
Time frame: immediately after the procedure
Total time of the procedure
Time frame: immediately after the procedure
Colonoscope withdrawal time from cecum
Time frame: immediately after the procedure
Demonstrate the non-inferiority of patient experience when comparing Endocuff Colonoscopy and Standard Colonoscopy
Time frame: through study completion, an average of 3 months
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 21 Nov 2022.
- 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?
A study testing Colonoscopy procedure with endocuff in people with Cancer Colorectal, run by Hospital Provincial de Castellon at 1 site in Spain.
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 12 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 21 Nov 2022. 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 Spain. 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?
polyps detection rate per patient (time frame: immediately after the 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?
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 21 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.