DiverticulitisNCT05832242
Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
An observational study of Diverticulitis, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Ultrasound
- How many people
- 1,125 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 16 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult emergency department patients suspected of having diverticulitis.
Who may be able to join
- Emergency department patient
- Provider suspicion of diverticulitis
- CT scan ordered
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
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
- Being tested
- Ultrasound
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Point-of-care ultrasound in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| Simple Diverticulitis | Computed tomograpy scan showing isolated inflammation Receives: Other: Ultrasound | |
| Complicated Diverticulitis | Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Diverticulitis
Computed tomography scan showing isolated inflammation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start28 Feb 2023
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Cohen, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832242
- Sponsor's protocol ID
- 22-0649
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound
- ClinicalTrials.gov ID
- NCT05832242
- Acronym / sponsor ID
- 22-0649
- Conditions
- Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Diverticulitis | – | Other: UltrasoundComputed tomograpy scan showing isolated inflammation |
| Complicated Diverticulitis | – | Other: UltrasoundComputed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult emergency department patients suspected of having diverticulitis.
Key inclusion criteria (3 listed)
- Emergency department patient
- Provider suspicion of diverticulitis
- CT scan ordered
Key exclusion criteria (7 listed)
- Pregnant patient
- Prisoner
- Non-English speaking
- Inability to provide informed consent
- Hemodynamically unstable as determined by provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundPoint-of-care ultrasound in the emergency department | Other | Complicated Diverticulitis, Simple Diverticulitis |
Primary outcome
Simple Diverticulitis
Time frame: 48 hours
Computed tomography scan showing isolated inflammation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diverticulitis
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APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
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Analysis of the Role of the Microbiota in Diverticular Disease
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Differentiating Right-sided Epiploic Appendagitis From Diverticulitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Cohen, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple Diverticulitis (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.