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SNCTP000004398 | NCT04676308 | BASEC2021-00732

Associazione di Endo-cuff ed intelligenza artificiale in un trial randomizzato per la valutazione mediante colonscopia.

Data source: BASEC (Imported from 07.05.2021), WHO (Imported from 18.04.2021)
Changed: 04.05.2021
Disease category: Colon and Rectal Cancer

Brief description of trial (Data source: BASEC)

Il progetto di ricerca studia la possibilità di poter utilizzare durante la colonscopia un sistema di identificazione dei polipi o tumori colorettali basato sull’intelligenza artificiale e lo associa all’utilizzo di un dispositivo chiamato Endo-cuff, in grado di distendere le anse intestinali coliche. Vogliamo sapere se l’utilizzo di questa combinazione dio sistemia migliora la capacità del medico che esegue l’esame di identificare lesioni che potrebbero essere dei tumori dell’intestino.

Health conditions investigated (Data source: BASEC)

polipi o tumori colorettali

Health conditions (Data source: WHO)

Artificial Intelligence

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Endo-cuff ed intelligenza artificiale

Interventions (Data source: WHO)

Other: Artificial Intelligence

Criteria for participation in trial (Data source: BASEC)

Verranno inclusi pazienti che saranno sottoposti ad una colonscopia con età compresa tra i 40 e 80 anni

Exclusion criteria (Data source: BASEC)

I pazienti non dovranno soffrire di malattie infiammatorie croniche intestinali, patologie pregresse come di neoplasie coliche o resezioni chirurgiche, di poliposi intestinale nota, inadeguata preparazione intestinale o terapie in atto anticoagulanti-antiaggreganti che non consentano la resezione di eventuali polipi.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- subjects undergoing a colonoscopy for gastrointestinal symptoms, fecal
immunohistochemical test positivity, primary screening or post-polypectomy
surveillance

Exclusion Criteria:

- subjects with personal history of CRC, or IBD.

- subjects affected with genetic mutations such as Lynch syndrome or Familiar
Adenomatous Polyposis.

- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale
> 2 in any colonic segment).

- patients with previous colonic resection.

- patients on antithrombotic therapy, precluding polyp resection.

- patients with history of colonic strictures, precluding ECV use.

- patients who were not able or refused to give informed written consent.

Minimum age: 40 Years
Maximum age: 80 Years
Sex: All

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04676308

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04676308

Further information on trial

Date trial registered

15.12.2020

Incorporation of the first participant

24.02.2021

Recruitment status

Not recruiting

Global completion date of trial

30.11.-0001

Academic title (Data source: WHO)

The CERTAIN Study: Combining Endo-cuff in a Randomized Trial for Artificial Intelligence Navigation

Type of trial (Data source: WHO)

Observational

Primary end point (Data source: WHO)

Diagnostic yield

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bellinzona

Countries (Data source: WHO)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Italy

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr.Med. Gianluca Lollo
+41918119353
gianluca.lollo@eoc.ch

Contact for general information (Data source: WHO)

Alessandro Repici, MD
0039-02-822247493
alessandro.repici@hunimed.eu

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Istituto Clinico Humanitas

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Comitato etico cantonale Ticino

Date of authorisation by the ethics committee

04.05.2021

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2021-00732

Secondary ID (Data source: WHO)

1766