Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors

NCT02383420 | Completed Results

• 1 other identifier: 6M2375
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Radlex Scale for Diagnostic Capability Ratings

  1-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-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-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.

  9 weeks after last x-ray capture

Secondary Outcomes (1)

• Pair Preference Rating Scale

  9 weeks after last x-ray capture

Study Arms (3)

Predicate & Invest-GOS

EXPERIMENTAL

Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.

Radiation: Radiation

Predicate & Invest-CsI

EXPERIMENTAL

Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.

Radiation: Radiation

Predicate & Invest.-Cadavers GOS & CsI

EXPERIMENTAL

Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.

Radiation: Radiation

Interventions

Radiation RADIATION

Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.

Predicate & Invest-CsI; Predicate & Invest-GOS; Predicate & Invest.-Cadavers GOS & CsI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• X-ray images of nearly identical positioning and exposure
• No visible image artifacts
• Subject 21 years or older
• Subject has provided informed consent
• Subject is in good general health (is able to be still to reduce the potential of motion in the images)
• Subject is able to stand for two (2) x-rays

You may not qualify if:

• Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
• Subject is pregnant or suspicious of being pregnant
• Subject 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:
• Subject has undergone radiation therapy
• Subject has had two (2) or more CT scans within the past year

Sponsors & Collaborators

• Carestream Health, Inc.: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Susan Pate, Senior Clinical Affairs Manager
• Organization: Carestream Health, Inc.

susan.pate@carestream.com

585-627-6557

Study Officials

• Susan Hobbs, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)