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

December 2, 2011
December 12, 2011
November 2008
December 2020   (final data collection date for primary outcome measure)
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.).
Same as current
Complete list of historical versions of study NCT01492231 on ClinicalTrials.gov Archive Site
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.)
Same as current
Not Provided
Not Provided
 
The Clinical Impact and Outcomes of Interventional Endoscopy Procedures
The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

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).

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Patients with gastrointestinal disease(s) undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Gastrointestinal Diseases
Not Provided
Chart Review
Chart review of patients who had a procedure done at H. H. Chao Comprehensive Digestive Disease Center
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
December 2020
December 2020   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01492231
HS#:2008-6258
Yes
Kenneth J. Chang, University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Kenneth Chang, MD University of California, Irvine
University of California, Irvine
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP