Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02557282
Other study ID # 9J8421
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date September 2015

Study information

Verified date March 2018
Source Carestream Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed Tomography (CT) Perfusion ("investigational device") imaging performance. Evaluation of CT Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with CT Perfusion Module.


Description:

This study will demonstrate the imaging performance CTP by an assessment of 30 CTP de-identified patient cases collected retrospectively. The purpose of the study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.

The maps include the following:

- Mean Transfer Time (MTT) - the time that the contrast material stays in the tissue

- Cerebral Blood Volume (CBV) - the volume of blood that is in a known volume of the tissue based on the concentration of contrast material that is in the tissue over the time

- Cerebral Blood Flow (CBF) - describes the flow of the blood to the affected tissue

- Time To Peak (TTP) - the time that maximum enhancement is achieved at each volume of the tissue

- Time to maximum of impulse response function (TMAX)

The retrospective data collected for each patient will include a non-contrast head CT exam completed on the same day as CTP image, and a follow-up head CT at least 1-2 days after the initial imaging study (initial non-contrast head CT) if available.

Similar performance between the investigational and predicate devices was demonstrated by the following criteria.

i. Substantial equivalence of the perfusion maps between devices ii. Substantial equivalence of the core and penumbra tissues resulting from thresholds on the perfusion maps between devices iii. The clinical decision based on the exclusion or inclusion criteria for treatment is equivalent between devices


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Retrospective patient CTP cases with case maps that include the following information: MTT, CBV, CBF, TTP, and TMAX.

- Initial CT exam and CT exam 1-2 days after the initial exam if available, and

- Retrospective CTP case with subject/patient 18 years of age or older

Exclusion Criteria:

- Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator,

- Subject less than 18 years of age

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Carestream Health, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device"). Demonstrate equivalent clinical quality between the investigational and predicate devices. one month
See also
  Status Clinical Trial Phase
Recruiting NCT05443061 - Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children N/A
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Recruiting NCT06006975 - Early Warning of Delayed Cerebral Ischemia
Completed NCT02758847 - Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Enrolling by invitation NCT02033681 - Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution N/A
Completed NCT01608035 - Sciatic Perineural Versus Stump Catheter for Below Knee Amputation Phase 0
Active, not recruiting NCT01518842 - Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy N/A
Completed NCT01625832 - Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study) N/A
Active, not recruiting NCT01281241 - Study on Mechanical and Electrical Alternans N/A
Completed NCT00778323 - Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery Phase 1/Phase 2
Completed NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) Phase 1/Phase 2
Terminated NCT00760708 - Circulating Adenosine Levels Before and After Intravenous (IV) Persantine
Not yet recruiting NCT06039748 - Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Completed NCT04879875 - New Method for Real-time Detection of Tissue Ischemia (ISCALERT) N/A
Completed NCT00526474 - Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737) Phase 3
Completed NCT03994822 - pRESET for Occlusive Stroke Treatment N/A
Completed NCT02910778 - The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males Phase 4
Completed NCT02552498 - Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging N/A
Completed NCT02703142 - Endoscopic Evaluation After Esophagectomy N/A