Efficacy and Safety of Endoscopic Resection

February 9, 2017 updated by: EDUARDO ALBENIZ
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

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

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.

Description

Inclusion Criteria:

  • Female and male patients who are at least 18 years old.
  • Clinical indication for endoscopic exam and endoscopic resection
  • Patients must freely accept their involvement in this study. They shall give a written informed consent

Exclusion Criteria:

  • Patients who do not desire to be included in this study

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
Time Frame
Proportion of complete resections without recurrence
Time Frame: 6 month post-endoscopic resection
6 month post-endoscopic resection

Collaborators and Investigators

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

Sponsor

EDUARDO ALBENIZ

Collaborators

Fundacion Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 25, 2013

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALB-RME-2013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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