Colorectal CancerENDOCOLESNCT03436004
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
A study testing Colonoscopy and Colonoscopy with specific device (Endocuff Vision) in people with Colorectal Cancer and Adenoma Colon, run by Dr. Alberto Herreros de Tejada Echanojáuregui at 8 sites in Spain.
Trial summary
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon
- What is being tested?
- Colonoscopy and Colonoscopy with specific device (Endocuff Vision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,453 participants
- Where
- 8 sitesSpain
- Study dates
- 18 May 2018to 4 Jun 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:
- Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.
- Patients invited to an opportunistic screening colonoscopy or included regional population screening program.
- Patients with a family history of CRC and indication of screening colonoscopy.
- Patients with follow-up colonoscopy indication by personal history of adenomas.
Who cannot join
- Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).
- Symptomatic patients with indication of diagnostic colonoscopy.
- Patients with a personal history of CRC.
- Patients with a personal history of chronic inflammatory bowel disease (IBD).
- Patients with a known personal history of hereditary CRC syndrome:
- No polyposis (Lynch syndrome). II. Polypic.
Show all 12Show fewer
- Patients with suspected attenuated polyposis (> 20 adenomas) with genetic diagnosis not defined.
- Patients with total or partial colic resection.
- Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year
- Pregnant or breastfeeding mothers.
- Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.
- Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Department of Gastroenterology, Hospital Universitario La Princesa
Madrid, 28006
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
Madrid, 28007
Department of Gastroenterology, Hospital Universitario Ramón y Cajal
Madrid, 28034
Department of Gastroenterology, Hospital Clínico San Carlos
Madrid, 28040
Department of Gastroenterology, Hospital Universitario 12 de Octubre
Madrid, 28041
Department of Gastroenterology, Hospital Universitario La Paz
Madrid, 28046
Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
Madrid, 28922
Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Read the detailed description
Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.
Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.
- Conditions
- Colorectal Cancer, Adenoma Colon
- Being tested
- Colonoscopy, Colonoscopy with specific device (Endocuff Vision)
- Keywords
- Colonoscopy, Adenoma, Adenoma detection rate
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDevice
Patients undergoing screening colonoscopy
Colonoscopy with specific device (Endocuff Vision)Device
Patients undergoing screening colonoscopy using the Endocuff Vision device
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Colonoscopy with specific device with CE marking (Endocuff Vision) Receives: Device: Colonoscopy with specific device (Endocuff Vision) |
| Active Comparator | Active comparator | Colonoscopy with standard device of the center Receives: Device: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
Number of adenoma detected by colonoscopy
Measured: 1 day
Mean adenoma per procedure (MAP)
Mean of adenoma detected by patient
Measured: 1 day
Secondary outcomes (3)
Total number of adenomas detected by colonoscopy
Measured: 1 day
Total number of advanced adenomas detected by colonoscopy
Measured: 1 day
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start18 May 2018
- Primary completion16 Apr 2019
- Study completion4 Jun 2019
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Multicenter prospective trial with medical device
- Masking
- None (open label)
- Enrolment
- 1,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Alberto Herreros de Tejada Echanojáuregui
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor-investigator, Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital
- Investigators
- Alberto Herreros de Tejada, MD, PhD, Principal investigator, Puerta de Hierro University HospitalAurora Burgos, MD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436004
- Sponsor's protocol ID
- ENDOCOLES
- Acronym
- ENDOCOLES
- Status last verified
- Aug 2019
- First submitted
- 26 Jan 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT03436004
- Acronym / sponsor ID
- ENDOCOLES / ENDOCOLES
- Conditions
- Colorectal Cancer, Adenoma Colon
- Keywords
- Colonoscopy, Adenoma, Adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,453 participants (actual)
- Lead sponsor
- Dr. Alberto Herreros de Tejada EchanojáureguiUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- 18 May 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 19 Feb 2018 (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.
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Detailed description
Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.
Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Multicenter prospective trial with medical device
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Colonoscopy with specific device (Endocuff Vision)Colonoscopy with specific device with CE marking (Endocuff Vision) |
| Active Comparator | Active comparator | Device: ColonoscopyColonoscopy with standard device of the center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:
- Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.
- Patients invited to an opportunistic screening colonoscopy or included regional population screening program.
- Patients with a family history of CRC and indication of screening colonoscopy.
- Patients with follow-up colonoscopy indication by personal history of adenomas.
Key exclusion criteria (12 listed)
- Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).
- Symptomatic patients with indication of diagnostic colonoscopy.
- Patients with a personal history of CRC.
- Patients with a personal history of chronic inflammatory bowel disease (IBD).
- Patients with a known personal history of hereditary CRC syndrome:
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 |
|---|---|---|
| ColonoscopyPatients undergoing screening colonoscopy | Device | Active Comparator |
| Colonoscopy with specific device (Endocuff Vision)Patients undergoing screening colonoscopy using the Endocuff Vision device | Device | Experimental |
Primary outcome
Adenoma detection rate (ADR)
Time frame: 1 day
Number of adenoma detected by colonoscopy
Mean adenoma per procedure (MAP)
Time frame: 1 day
Mean of adenoma detected by patient
3 secondary outcomes
Total number of adenomas detected by colonoscopy
Time frame: 1 day
Total number of advanced adenomas detected by colonoscopy
Time frame: 1 day
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Time frame: 1 day
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 22 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Alberto Herreros de Tejada, MD, PhD principal investigator
Puerta de Hierro University Hospital
Aurora Burgos, MD principal investigator
La Paz University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and Colonoscopy with specific device (Endocuff Vision) in people with Colorectal Cancer and Adenoma Colon, run by Dr. Alberto Herreros de Tejada Echanojáuregui at 8 sites 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 5 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 22 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 8 sites 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?
Adenoma detection rate (ADR) (time frame: 1 day). 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 22 Aug 2019.