Recruiting

Decision Tool

Sponsor:

Northwell Health

Code:

NCT05832242

Conditions

Diverticulitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Study Details

Brief 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

Conditions

Diverticulitis

Study ID

NCT05832242

Start date

Feb 28, 2023

Status verified date

Apr, 2023

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Simple Diverticulitis

Computed tomograpy scan showing isolated inflammation

Complicated Diverticulitis

Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation.

Interventions

Ultrasound

Point-of-care ultrasound in the emergency department

Primary outcome measure

  • Simple Diverticulitis [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Timmy Li, PhD

5162403933tli2@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Timmy Li, PhD

516-240-3933tli2@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Apr 27, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-04-27.