The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Gastrointestinal Diseases Clinical Trial

Official title:

The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01492231
• Other study ID #: 20086258
• Status: Enrolling by invitation
• Start date: November 2008
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3500
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	H. H. Chao Comprehensive Digestive Disease Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and clinical management data	Outcome data includes clinical management (such as hospitalization information, and complications, costs associated with endoscopy procedures, etc.).	Day of procedure up to 5 years for follow-up (if needed).
Secondary	Collect Performance Data	Outcome performance data (such as, technical success, procedure time, rate of repeat interventions, lab/pathology results, etc.)	Day of procedure up to 5 years for follow-up (if needed).