Back to resultsEvaluation of Colonoscopy With a Specific Device for the Detection of Adenomas (ENDOCOLES)
Primary Purpose
Colorectal Cancer, Adenoma Colon
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Colonoscopy
Colonoscopy with specific device (Endocuff Vision)
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy, Adenoma, Adenoma detection rate
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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:
I. No polyposis (Lynch syndrome). II. Polypic.
- 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.
Sites / Locations
- Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
- Department of Gastroenterology, Hospital Universitario La Princesa
- Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
- Department of Gastroenterology, Hospital Universitario Ramón y Cajal
- Department of Gastroenterology, Hospital Clínico San Carlos
- Department of Gastroenterology, Hospital Universitario 12 de Octubre
- Department of Gastroenterology, Hospital Universitario La Paz
- Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Active Comparator
Arm Description
Colonoscopy with specific device with CE marking (Endocuff Vision)
Colonoscopy with standard device of the center
Outcomes
Primary Outcome Measures
Adenoma detection rate (ADR)
Number of adenoma detected by colonoscopy
Mean adenoma per procedure (MAP)
Mean of adenoma detected by patient
Secondary Outcome Measures
Total number of adenomas detected by colonoscopy
Total number of advanced adenomas detected by colonoscopy
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Full Information
NCT ID
NCT03436004
First Posted
January 26, 2018
Last Updated
August 20, 2019
Sponsor
Dr. Alberto Herreros de Tejada Echanojáuregui
Collaborators
Spanish Clinical Research Network - SCReN
1. Study Identification
Unique Protocol Identification Number
NCT03436004
Brief Title
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
Acronym
ENDOCOLES
Official Title
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Alberto Herreros de Tejada Echanojáuregui
Collaborators
Spanish Clinical Research Network - SCReN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenoma Colon
Keywords
Colonoscopy, Adenoma, Adenoma detection rate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Multicenter prospective trial with medical device
Masking
None (Open Label)
Masking Description
Concealed assignation
Allocation
Randomized
Enrollment
1453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Colonoscopy with specific device with CE marking (Endocuff Vision)
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Colonoscopy with standard device of the center
Intervention Type
Device
Intervention Name(s)
Colonoscopy
Intervention Description
Patients undergoing screening colonoscopy
Intervention Type
Device
Intervention Name(s)
Colonoscopy with specific device (Endocuff Vision)
Intervention Description
Patients undergoing screening colonoscopy using the Endocuff Vision device
Primary Outcome Measure Information:
Title
Adenoma detection rate (ADR)
Description
Number of adenoma detected by colonoscopy
Time Frame
1 day
Title
Mean adenoma per procedure (MAP)
Description
Mean of adenoma detected by patient
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Total number of adenomas detected by colonoscopy
Time Frame
1 day
Title
Total number of advanced adenomas detected by colonoscopy
Time Frame
1 day
Title
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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:
I. No polyposis (Lynch syndrome). II. Polypic.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Herreros de Tejada, MD, PhD
Organizational Affiliation
Puerta de Hierro University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aurora Burgos, MD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
City
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
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