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Enrolling by invitationNCT01492231Updated Feb 26, 2024

The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

An observational study in Gastrointestinal Diseases, sponsored by University of California, Irvine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by University of California, Irvine · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
3,500
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Gastrointestinal Diseases

Keywords

  • gastroenterology
  • Endoscopy, Digestive System
  • Endosonography
  • Endoscopic Retrograde Cholangiopancreatography
  • gastrointestinal endoscopy
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 3,500 is above the median of 325 across 190 observational studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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).
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
3,500 participants (estimated)

Groups and cohorts

  • Chart Review

    Chart review of patients who had a procedure done at H. H. Chao Comprehensive Digestive Disease Center

06

What researchers measure

Primary outcomes

  1. Collect and clinical management data

    Outcome data includes clinical management (such as hospitalization information, and complications, costs associated with endoscopy procedures, etc.).

    Time frame: Day of procedure up to 5 years for follow-up (if needed).

Secondary outcomes

  1. Collect Performance Data

    Outcome performance data (such as, technical success, procedure time, rate of repeat interventions, lab/pathology results, etc.)

    Time frame: Day of procedure up to 5 years for follow-up (if needed).

07

Study locations

1 site
  • H. H. Chao Comprehensive Digestive Disease Center
    Orange, California 92868, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01492231
Lead sponsor
University of California, Irvine
Responsible party
Kenneth J. Chang (Professor of Clinical Medicine, University of California, Irvine) — Principal investigator
First posted
Dec 14, 2011
Start date
Nov 2008
Primary completion
Sep 2025 (estimated)
Completion
Sep 2026 (estimated)
Last update
Feb 26, 2024

Study contacts

Kenneth Chang, MD
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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