NCT01492231

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Nov 2008Sep 2026

Study Start

First participant enrolled

November 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

16.8 years

First QC Date

December 2, 2011

Last Update Submit

February 22, 2024

Conditions

Gastrointestinal Diseases

Keywords

gastroenterologyEndoscopy, Digestive SystemEndosonographyEndoscopic Retrograde Cholangiopancreatographygastrointestinal endoscopy

Outcome Measures

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.).

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

Secondary Outcomes (1)

  • Collect Performance Data

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

Study Arms (1)

Chart Review

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. H. Chao Comprehensive Digestive Disease Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Kenneth Chang, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Medicine

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 14, 2011

Study Start

November 1, 2008

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(1)