Last reviewed · How we verify

NCT03687502

The Role of Contrast Enhanced Ultrasound in Appendicitis

Completed Phase 2 Results posted Last updated 8 September 2023
What this trial tests

Phase 2 trial testing Sulfur hexafluoride lipid-type A microspheres in Acute Appendicitis in 37 participants. Completed in 5 July 2022.

Timeline
4 January 2019
Primary endpoint
26 March 2021
5 July 2022

Quick facts

Lead sponsorChildren's Mercy Hospital Kansas City
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment37
Start date4 January 2019
Primary completion26 March 2021
Estimated completion5 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Mercy Hospital Kansas City

Who can join

Adults 8 to 17, any sex, with Acute Appendicitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Children With an Accurate Diagnosis of Appendicitis. Primary · 1 week

Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories: Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis

GroupValue95% CI
Contrast Enhanced Ultrasound Group6
Contrast Enhanced Ultrasound Group15
Contrast Enhanced Ultrasound Group1
Contrast Enhanced Ultrasound Group13
Definitive Diagnosis Secondary · 1 week

Proportion of children with definitive diagnosis of appendicitis with use of CEUS.

GroupValue95% CI
Contrast Enhanced Ultrasound Group13
Number of Participants Who Required Additional CT Scan Secondary · 30 days

"Number of Participants who Required Additional CT Scan"

GroupValue95% CI
Experimental0
Percentage of Negative Appendectomies Secondary · 1 week

Percentage of negative appendectomies

GroupValue95% CI
Contrast Enhanced Ultrasound Group1
Total Cost Difference Compared to Traditional Ultrasound Secondary · 60 days

Costs in comparison to traditional ultrasound

GroupValue95% CI
Contrast Enhanced Ultrasound Group16
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. Secondary · 60 days

Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.

GroupValue95% CI
Contrast Enhanced Ultrasound Group6198

Sponsor's own description

This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Sulfur hexafluoride lipid-type A microspheres

Trials testing the same drug.

Other recruiting trials for Acute Appendicitis

Currently open trials in the same condition.

Other Children's Mercy Hospital Kansas City trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03687502.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing