Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

17. marts 2021 opdateret af: Istituto Clinico Humanitas

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
      • Rozzano, Italien, 20089
        • Humanitas Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TRS
TRS, Tissue resection system
Enhed: TRS, Tissue Retraction System
Tissue Retraction System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS.
Tidsramme: 9 months
9 months

Sekundære resultatmål

Resultatmål
Tidsramme
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).
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istituto Clinico Humanitas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2018

Primær færdiggørelse (Faktiske)

31. december 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

29. maj 2018

Først indsendt, der opfyldte QC-kriterier

11. juni 2018

Først opslået (Faktiske)

12. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • TRS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tissue Retraction System

Kliniske forsøg med TRS, Tissue Retraction System

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner