Developing a Decision Tool for Diverticulitis in the Emer... | NCT05832242

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

NCT05832242

Sponsor

Northwell Health

Status

Unknown status

Last Update Posted

Apr 27, 2023Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Diverticulitis

Interventions

Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2023Actual

Primary Completion Date

Feb 28, 2025Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Mar 15, 2023

First Submission Date that Met QC Criteria

Apr 14, 2023

First Posted Date

Apr 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple Diverticulitis		Computed tomograpy scan showing isolated inflammation	Other: Ultrasound
Complicated Diverticulitis		Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation.	Other: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Other	Point-of-care ultrasound in the emergency department	Complicated Diverticulitis Simple Diverticulitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Simple Diverticulitis	Computed tomography scan showing isolated inflammation	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult emergency department patients suspected of having diverticulitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timmy Li, PhD	Contact	5162403933		tli2@northwell.edu

Overall Officials

Name	Affiliation	Role
Allison Cohen, MD	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Shore University Hospital	Recruiting	Manhasset	New York	11030	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004238	Diverticulitis

Ancestor Terms

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided