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The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

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ClinicalTrials.gov Identifier: NCT01492231
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2011
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main purpose of the protocol is to collect and evaluate performance data after patients undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Condition or disease
Gastrointestinal Diseases

Detailed Description:
In general, the outcome data includes clinical management, hospitalization, and complications; to determine costs associated with endoscopy procedures; to determine performance data including technical success, procedure time, rate of repeat interventions; to compare endoscopy performance and outcome data collected at University of California, Irvine (UCI) and results from other institutions previously published in the literature. Additional parameters might be collected for specific interventional endoscopy procedures.

Study Design

Study Type : Observational
Estimated Enrollment : 3500 participants
Time Perspective: Retrospective
Official Title: The Clinical Impact and Outcomes of Interventional Endoscopy Procedures
Study Start Date : November 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Chart Review
Chart review of patients who had a procedure done at H. H. Chao Comprehensive Digestive Disease Center


Outcome Measures

Primary Outcome Measures :
  1. Collect and clinical management data [ Time Frame: Day of procedure up to 5 years for follow-up (if needed). ]
    Outcome data includes clinical management (such as hospitalization information, and complications, costs associated with endoscopy procedures, etc.).


Secondary Outcome Measures :
  1. Collect Performance Data [ Time Frame: Day of procedure up to 5 years for follow-up (if needed). ]
    Outcome performance data (such as, technical success, procedure time, rate of repeat interventions, lab/pathology results, etc.)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with gastrointestinal disease(s) undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).
Criteria

Inclusion Criteria:

  • Subjects who are 18 years of age or older
  • Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Exclusion Criteria:

  • Subjects who are not 18 years of age or older
  • Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).
Contacts and Locations

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): NCT01492231


Locations
United States, California
H. H. Chao Comprehensive Digestive Disease Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Kenneth Chang, MD University of California, Irvine
More Information

Responsible Party: Kenneth J. Chang, Professor of Clinical Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01492231     History of Changes
Other Study ID Numbers: HS#:2008-6258
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Kenneth J. Chang, University of California, Irvine:
gastroenterology
Endoscopy, Digestive System
Endosonography
Endoscopic Retrograde Cholangiopancreatography
gastrointestinal endoscopy

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases