Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04280393 |
| Other study ID # |
FCVHPC-2018-PS-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Hospital Provincial de Castellon |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
