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NCT03553199: TRS

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

Completed NA Last updated 18 March 2021
What this trial tests

NA trial testing TRS, Tissue Retraction System in Tissue Retraction System in 15 participants. Completed in 31 December 2020.

Timeline
28 May 2018
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorIstituto Clinico Humanitas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date28 May 2018
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Clinico Humanitas

Who can join

18 and older, any sex, with Tissue Retraction System. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Istituto Clinico Humanitas trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03553199.

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