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
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Further information on trial
Date trial registered
Dec 15, 2020
Incorporation of the first participant
Feb 24, 2021
Recruitment status
Not recruiting
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
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
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