The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

• Conditions: Gastrointestinal Diseases

• Registration Number: NCT01492231
• Lead Sponsor: University of California, Irvine

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).

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect and clinical management data	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

Name	Time	Method
Collect Performance Data	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.)

Trial Locations

Locations (1)

H. H. Chao Comprehensive Digestive Disease Center; 🇺🇸 Orange, California, United States