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Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System (TRS)

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ClinicalTrials.gov Identifier: NCT03553199
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief 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.


Condition or disease Intervention/treatment Phase
Tissue Retraction System Device: TRS, Tissue Retraction System Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: TRS
TRS, Tissue resection system
Device: TRS, Tissue Retraction System
Tissue Retraction System




Primary Outcome Measures :
  1. Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Secondary endpoints are: the efficacy, defined as the rate of lesions removed enbloc and the rate of curative ESD (with an R0 resection); the safety, defined as the rate of adverse events (AEs). [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • left colon and rectal lesions matching the criteria of ESD removal: depressed/flat elevated morphology and irregular or nongranular surface pattern, larger than 20 mm; lesions that cannot be optimally and radically removed with standard polypectomy or EMR
  • age ≥18 years
  • ability to sign the informed consent

Exclusion Criteria:

  • deep submucosal invasion diagnosed by distorted pit (Kudo's type V) and/or capillary (Sano's type III) patterns [5];
  • poor general condition (American Society of Anesthesiologists score ≥ 3);
  • coagulation disorders;
  • pregnancy and breastfeeding;
  • inability to sign the informed consent.

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): NCT03553199


Contacts
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Contact: Alessandro Repici, MD 0039-02-82247493 alessandro.repici@hunimed.eu
Contact: Roberta Maselli, MD 0039-02-82247570 roberta.maselli@humanitas.it

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Italy, 20089
Contact: Alesandro Repici, MD    0039-02-82247493    alessandro.repici@hunimed.eu   
Sponsors and Collaborators
Istituto Clinico Humanitas

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03553199     History of Changes
Other Study ID Numbers: TRS
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Istituto Clinico Humanitas:
Tissue Retraction System
Colorectal polyps