Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03553199 |
| Other study ID # |
TRS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Istituto Clinico Humanitas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of
lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy
(ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed
enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that
are > 20 mm in diameter, with a high probability of having a limited submucosal invasion.
ESD is a technically difficult and time-consuming procedure that is very difficult to learn
and to perform, but it allows higher enbloc resection rates compared to other endoscopic
techniques and is less invasive than surgery requiring less length of hospital stay.
Recently, several new techniques and devices have been developed to facilitate ESD and to
overcome difficulties related to challenging situations. The main difficulties are related to
the instability of the operating field, due to the physiologic peristalsis, and to the loss
of traction, due to the single operating channel.
Description:
Tissue Retraction System (TRS, Boston scientific) is a new endoscopic platform, that consists
of an expandable and dynamically-controlled intra-luminal chamber, mounted on a flexible
overtube, and two associated specifically designed retractor graspers. The system is
front-loaded over the colonoscope and introduced into the colon. When the target area is
reached, the retractor system is deployed creating an expanded, optimally reconfigured and
stable operating field around the target lesion. Then endoscopic removal of the lesion is
performed using available endoscopic instruments (injection needles, knives, snares, etc)
through the operating channel of the colonoscope with assistance of two retractor graspers.
Each accessory within the TRS can be moved forward and backward, left or right, rotated 360
degrees, and can be advanced out and pulled in, regardless of the TRS.
The investigators hypothesize that the TRS can improve visualization of lesions and stabilize
the work environment by allowing retraction and tissue resection during ESD.
TRS is a new device not yet commercially available, thus no study has been already performed
in humans to evaluate its feasibility and safety to speed up the ESD of left colon and rectum
lesions.
The investigator's proposal is to perform a pilot study to evaluate the feasibility, the
efficacy and the safety in patients undergoing ESD of colorectal lesions with the assistance
of the TRS.
