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NCT05832242 Clinical Trial

Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

Diverticulitis Clinical Trial

Official title:
Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05832242
Other study ID # 22-0649
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 28, 2023
Est. completion date February 28, 2025

Study information
Verified date April 2023
Source Northwell Health
Contact Timmy Li, PhD
Phone 5162403933
Email tli2@northwell.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Emergency department patient - Provider suspicion of diverticulitis - CT scan ordered Exclusion Criteria: - Pregnant patient - Prisoner - Non-English speaking - Inability to provide informed consent - Hemodynamically unstable as determined by provider - Previous abdominal surgery within last 7 days - Unable to lay flat for ultrasound exam

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ultrasound
Point-of-care ultrasound in the emergency department

Locations
Country Name City State
United States North Shore University Hospital Manhasset New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Simple Diverticulitis Computed tomography scan showing isolated inflammation 48 hours
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