EUS for Gastrointestinal Disorders: a Registry

GI Tract Disorders Clinical Trial

Official title:

EUS for Gastrointestinal Disorders: a Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855151
• Other study ID #: 1497
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Istituto Clinico Humanitas
• Contact: Silvia Carrara, MD
• Phone: +390282247288
• Email: silvia.carrara[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients submitted to EUS,

• Informed consent.

Exclusion Criteria:

• Age less than 18 y

• Patient who did not give the consent to the processing of personal data.

Related Conditions & MeSH terms

• Digestive System Diseases
• Disease
• EUS
• Gastrointestinal Diseases
• GI Tract Disorders
• Pancreatic Diseases
• Pancreatic Disorders

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events	Documentation of adverse events.	2 days
Secondary	Diagnostic yied of elastography during EUS	sensitivity and specificity of EUS with elastography	0 Day
Secondary	Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography	sensitivity and specificity contrast medium	0 Day
Secondary	Tissue acquisition during EUS	sensitivity and specificity of tissue acquisition	0 Days