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Efficacy and Safety of Endoscopic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050333
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Fundacion Miguel Servet
Information provided by (Responsible Party):
EDUARDO ALBENIZ, Fundacion Miguel Servet

Study Description
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Brief Summary:
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.

Condition or disease
Endoscopic Resection Gastrointestinal Neoplasms

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy and Safety of Endoscopic Resection
Actual Study Start Date : April 25, 2013
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of complete resections without recurrence [ Time Frame: 6 month post-endoscopic resection ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050333


Contacts
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Contact: EDUARDO ALBENIZ, MD edualbeniz@hotmail.com

Locations
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Spain
Eduardo Albeniz Arbizu Recruiting
Pamplona, Navarra, Spain, 31008
Contact: EDUARDO ALBENIZ, MD       edualbeniz@hotmail.com   
Contact: FERRAN CAPDEVILA, PHARMD       fcapdevb@navarra.es   
Principal Investigator: EDUARDO ALBENIZ, MD         
Sponsors and Collaborators
EDUARDO ALBENIZ
Fundacion Miguel Servet
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Albéniz E, Gimeno-García AZ, Fraile M, Ibáñez B, Guarner-Argente C, Alonso-Aguirre P, Álvarez MA, Gargallo CJ, Pellisé M, Ramos Zabala F, Herreros de Tejada A, Nogales Ó, Martínez-Ares D, Múgica F, de la Peña J, Espinós J, Huerta A, Álvarez A, Gonzalez-Santiago JM, Navajas F, Martínez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sábado F, Rivero L, Saperas E, Soto S, Rodríguez-Sánchez J, López-Roses L, Rodríguez-Téllez M, Rullán Iriarte M, Elosua González A, Pardeiro R, Valdivielso Cortázar E, Concepción-Martín M, Huelin Álvarez P, Colán Hernández J, Cobian J, Santiago J, Jiménez A, Remedios D, López-Viedma B, García O, Martínez-Alcalá F, Pérez-Roldán F, Carbó J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.

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Responsible Party: EDUARDO ALBENIZ, MD, Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT03050333    
Other Study ID Numbers: ALB-RME-2013-01
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases