Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)
perjantai 2. joulukuuta 2016 päivittänyt: Carestream Health, Inc.
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices.
The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US.
The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.
The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.
The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
48
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Subject 18 years or older
- Subject has provided informed consent
- Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images.
- Subject(s) may have a metal screw, plate or artificial joint
Exclusion Criteria:
- Subject is pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
- Has undergone radiation therapy
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Diagnostiikka
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Predicate & Invest.- Cadavers 2D & 3D
Radiation - Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
|
Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.
|
|
Kokeellinen: Investigational - Human Subjects 3D
Radiation - Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
|
Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Radlex Scale for Diagnostic Quality Ratings - 2D Images
Aikaikkuna: 12 weeks after last image capture
|
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes.
Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact).
Almost all such imaging should be repeated.
2-2.9-Limited
Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes).
Not as much diagnostic information as is typical for an examination of this type, but likely sufficient.
3-3.9-Diagnostic
Image quality that would be expected routinely when imaging cooperative patients.
4-Exemplary Good, most adequate for diagnostic purposes.
Image quality that can serve as an example that should be emulated.
|
12 weeks after last image capture
|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution
Aikaikkuna: 12 weeks after last image capture
|
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes.
Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact).
Almost all such imaging should be repeated.
2-2.9-Limited
Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes).
Not as much diagnostic information as is typical for an examination of this type, but likely sufficient.
3-3.9-Diagnostic
Image quality that would be expected routinely when imaging cooperative patients.
4-Exemplary Good, most adequate for diagnostic purposes.
Image quality that can serve as an example that should be emulated.
|
12 weeks after last image capture
|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK
Aikaikkuna: 12 weeks after last image capture
|
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes.
Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact).
Almost all such imaging should be repeated.
2-2.9-Limited
Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes).
Not as much diagnostic information as is typical for an examination of this type, but likely sufficient.
3-3.9-Diagnostic
Image quality that would be expected routinely when imaging cooperative patients.
4-Exemplary Good, most adequate for diagnostic purposes.
Image quality that can serve as an example that should be emulated.
|
12 weeks after last image capture
|
|
Radlex Scale for Diagnostic Quality Ratings - 3D Images SND
Aikaikkuna: 12 weeks after last image capture
|
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes.
Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact).
Almost all such imaging should be repeated.
2-2.9-Limited
Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes).
Not as much diagnostic information as is typical for an examination of this type, but likely sufficient.
3-3.9-Diagnostic
Image quality that would be expected routinely when imaging cooperative patients.
4-Exemplary Good, most adequate for diagnostic purposes.
Image quality that can serve as an example that should be emulated.
|
12 weeks after last image capture
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: John Marzo, MD, UBMD Orthopaedics & Sports Medicine
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. syyskuuta 2015
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. marraskuuta 2015
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. marraskuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 11. toukokuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 12. toukokuuta 2015
Ensimmäinen Lähetetty (Arvio)
Perjantai 15. toukokuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Maanantai 30. tammikuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 2. joulukuuta 2016
Viimeksi vahvistettu
Perjantai 1. toukokuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- 6M3388
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .