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OpenTrials
Enrolling by Invitation

NCT Number: NCT01492231

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).

Enrolling by Invitation

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H. H. Chao Comprehensive Digestive Disease Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Collect and clinical management data

    Time frame: 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 outcomes

  1. Collect Performance Data

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2008
Primary completion
2025
Study completion
2026
First posted
Dec 14, 2011
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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