Colorectal CanceerNCT02387593
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study
A study testing ENDOCUFF in people with Colorectal Canceer, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong. The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Canceer
- What is being tested?
- ENDOCUFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2014to Apr 2015
- 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
- Healthy adult patients,
- Aged 18,
- Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies
Who cannot join
- Boston colonic preparation <5 points
- Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Rafael Barreto
México, Tlalpan, 14000
Rafael Barreto, MD, 54870900 ext. 2150, barretozu@yahoo.com
About this study
Official title: Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.
The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.
The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.
There is insufficient evidence of the usefulness of endocuf
Read the detailed description
All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.
- Conditions
- Colorectal Canceer
- Being tested
- ENDOCUFF
- Keywords
- Adenoma, Colonoscopy, Screening
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOCUFFDevice
One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy with endocuff | Experimental | To the usual colonoscopy will place a endocuff at the tip of the colonoscope Receives: Device: ENDOCUFF |
| standard colonoscopy without endocuff | No intervention | Routine colonoscopy without endocuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Percentage of adenomas detected during colonoscopy
Measured: 30 minutes
Measurement of the polyp detection rate
Percentage of polyps detected during colonoscopy
Measured: 30 minutes
Secondary outcomes (4)
Cecal intubation rate
Percentage of cecal intubation
Measured: 30 minutes
ileal intubation rate
Percentage of ileal intubation
Measured: 10 minutes
Difficulty performing polypectomy
When the endoscopist requiring special maneuvers to perform polypectomy
Measured: 10 minutes
Complications during colonoscopy
When patients require special handling during or immediately subsequent colonoscopy
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CanceerStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rafael Barreto Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Rafael Rafael, MD, Principal investigator, Department of Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387593
- Sponsor's protocol ID
- END-1302-14/15-1
- Status last verified
- Sep 2014
- First submitted
- 9 Mar 2015
- Last updated
- 13 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02387593
- Acronym / sponsor ID
- END-1302-14/15-1
- Conditions
- Colorectal Canceer
- Keywords
- Adenoma, Colonoscopy, Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- 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.
Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.
The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.
The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.
There is insufficient evidence of the usefulness of endocuf
Detailed description
All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colonoscopy with endocuff | Experimental | Device: ENDOCUFFTo the usual colonoscopy will place a endocuff at the tip of the colonoscope |
| standard colonoscopy without endocuff | No intervention | –Routine colonoscopy without endocuff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult patients,
- Aged 18,
- Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies
Key exclusion criteria (2 listed)
- Boston colonic preparation <5 points
- Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
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 |
|---|---|---|
| ENDOCUFFOne endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline | Device | colonoscopy with endocuff |
Primary outcome
Adenoma detection rate
Time frame: 30 minutes
Percentage of adenomas detected during colonoscopy
Measurement of the polyp detection rate
Time frame: 30 minutes
Percentage of polyps detected during colonoscopy
4 secondary outcomes
Cecal intubation rate
Time frame: 30 minutes
ileal intubation rate
Time frame: 10 minutes
Difficulty performing polypectomy
Time frame: 10 minutes
Complications during colonoscopy
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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.
Rafael Rafael, MD principal investigator
Department of Endoscopy
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 in people with Colorectal Canceer, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Mar 2015. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael RB Barreto Zúñiga, MD (0155- 54870900 ext. 2150, barretozu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 30 minutes). 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 13 Mar 2015.