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The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kenneth J. Chang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01492231
First received: December 2, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Gastrointestinal Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Collect and clinical management data [ Time Frame: Day of procedure up to 5 years for follow-up (if needed). ] [ Designated as safety issue: No ]
    Outcome data includes clinical management (such as hospitalization information, and complications, costs associated with endoscopy procedures, etc.).


Secondary Outcome Measures:
  • Collect Performance Data [ Time Frame: Day of procedure up to 5 years for follow-up (if needed). ] [ Designated as safety issue: No ]
    Outcome performance data (such as, technical success, procedure time, rate of repeat interventions, lab/pathology results, etc.)


Estimated Enrollment: 1000
Study Start Date: November 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chart Review
Chart review of patients who had a procedure done at H. H. Chao Comprehensive Digestive Disease Center

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013