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Enrolling by invitation NCT01492231

The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Observational Gastrointestinal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastrointestinal Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Collect and clinical management data [Time frame: Day of procedure up to 5 years for follow-up (if needed).]
Secondary outcome measures (1)
  • Collect Performance Data [Time frame: Day of procedure up to 5 years for follow-up (if needed).]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • H. H. Chao Comprehensive Digestive Disease Center — Orange

Identifiers

NCT: NCT01492231 · 20086258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗