Registry for Advanced Endoscopy (ERDB)

April 11, 2024 updated by: Region Stockholm

Research Registry for Endoscopic Treatment and Diagnostics

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 18146
        • Recruiting
        • Karolinska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for endoscopic procedures at Karolinska University Hospital

Description

Inclusion Criteria:

  • Clinical indication for endoscopic intervention/procedure

Exclusion Criteria:

  • No informed consent
  • Age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Erik von Seth, MD, PhD, Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Estimated)

January 14, 2032

Study Completion (Estimated)

January 14, 2032

Study Registration Dates

First Submitted

December 25, 2021

First Submitted That Met QC Criteria

December 25, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-7616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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