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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05187312
Other study ID # 2021-7616
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date January 14, 2032

Study information

Verified date April 2024
Source Region Stockholm
Contact Erik von Seth, MD, PhD
Phone +46812380000
Email erik.von.seth@ki.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 14, 2032
Est. primary completion date January 14, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical indication for endoscopic intervention/procedure Exclusion Criteria: - No informed consent - Age <18 years

Study Design


Intervention

Procedure:
Endoscopic retrograde Cholangio- pancreatography
Endoscopic intervention in the biliary or pancreatic duct
Endoscopic ultrasound
Endoscopic investigation/intervention with ultrasound

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Region Stockholm Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Incidence of Adverse events following endoscopic procedures. Measured as percentage of individuals with an adverse event 30-days and 60-days post-procedure
Primary Diagnostic yield Diagnostic yield after tissue sampling 1-year follow up
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