Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280393
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Fernando Sabado Marti, Hospital Provincial de Castellon

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cancer Colorectal Device: Colonoscopy procedure with endocuff Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : February 12, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Endocuff
Colonoscopy procedure with the use of endocuff
Device: Colonoscopy procedure with endocuff
Colonoscopy procedure with the use of ENDOCUFF VISION

Active Comparator: Control
Standard Colonoscopy procedure
Device: Colonoscopy procedure with endocuff
Colonoscopy procedure with the use of ENDOCUFF VISION




Primary Outcome Measures :
  1. polyps detection rate per patient [ Time Frame: immediately after the procedure ]
    Rate of polyps detected

  2. adenoma detection rate per patient [ Time Frame: immediately after the procedure ]
    Rate of Adenoma detected


Secondary Outcome Measures :
  1. differences in the mean of adenomas detected by patient [ Time Frame: immediately after the procedure ]
    Assess whether there are differences in the mean of adenomas detected by patient comparing Endocuff Colonoscopy and Standard Colonoscopy.

  2. Serrated adenoma rate detected by patient [ Time Frame: immediately after the procedure ]
    Rate of serrated adenomas

  3. Cancer lesion detection rate comparing Endocuff Colonoscopy and Standard Colonoscopy. [ Time Frame: immediately after the procedure ]
    Rate of lessions

  4. Cecal intubation rate and time to reach the cecum [ Time Frame: immediately after the procedure ]
    Time in minutes of the intubation

  5. Total time of the procedure [ Time Frame: immediately after the procedure ]
    Total time of the procedure, from the insertion of the colonoscope to its extraction comparing Endocuff Colonoscopy and Standard Colonoscopy.

  6. Colonoscope withdrawal time from cecum [ Time Frame: immediately after the procedure ]
    Colonoscope withdrawal time from cecum in patients in whom no polyps were detected

  7. Demonstrate the non-inferiority of patient experience when comparing Endocuff Colonoscopy and Standard Colonoscopy [ Time Frame: through study completion, an average of 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A) Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program.

B) With the ability to provide informed consent

Exclusion Criteria:

  1. History of inflammatory bowel disease
  2. History or suspected obstruction or intestinal pseudo-obstruction located in the colon
  3. History of colon cancer or polyposic syndromes
  4. History of colonic stenosis
  5. History of severe diverticular segments in some region of the colon
  6. Subjects unable to provide informed consent
  7. 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
  8. Pregnants females
  9. Subjects who are going to undergo a therapeutic or surveillance endoscopy for follow-up of injuries diagnosed in previous procedures
  10. Subjects whose baseline status does not allow the completion of the questionnaires necessary for the evaluation of the study objectives.
  11. History of previous colonic surgery except for appendectomy
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280393


Contacts
Layout table for location contacts
Contact: Francisco Garcia, MSc +34 964 354458 francisco.garpi@hospitalprovincial.es

Locations
Layout table for location information
Spain
Hospital Provincial de Castellon Recruiting
Castellón De La Plana, Castellon, Spain, 12002
Contact: FRANCISCO GARCIA PINON    +34 964 354458    francisco.garpi@hospitalprovincial.es   
Contact: FERNANDO SABADO MARTI, MD    +34 964 35 97 00 ext 54060    fersabado@hotmail.com   
Sponsors and Collaborators
Hospital Provincial de Castellon

Layout table for additonal information
Responsible Party: Fernando Sabado Marti, Principal Investigator, Hospital Provincial de Castellon
ClinicalTrials.gov Identifier: NCT04280393    
Other Study ID Numbers: FCVHPC-2018-PS-01
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Fernando Sabado Marti, Hospital Provincial de Castellon:
adenoma
colonoscopy
endocuff
screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases