Trial Outcomes & Findings for Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury (NCT NCT01927575)

Results Overview

Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Baseline Imaging Collection

Results posted on

2020-06-04

Participant Flow

Subjects who present for, are undergoing, or have undergone 'standard of care' general x-ray and CT or MRI examinations, which meet all of the study enrollment criteria, may be approached and enrolled. Each subject would then have a 3rd image taken using Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.

Subjects are recruited as long as they had either an x-ray and CT or an x-ray and MRI, and sign a consent to have a third image taken with Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.

Participant milestones

Participant milestones
Measure	All Study Participants Standard of care X-Ray imaging plus CT to be compared with research imaging device. Standard X-Ray: Standard of Care X-Ray Imaging + CT Followed by Tomo Imaging
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=1 Participants Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis. Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT Followed by Tomo Imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline Imaging Collection

Population: Three sets (1 - X-ray, 1- CT and 1 - Digital Tomosynthesis) of images of the tibia evaluated to confirm acceptable image quality and provided clinical and diagnostic value.

Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.

Outcome measures

Outcome measures
Measure	Standard X-Ray n=1 Participants Standard of care X-Ray imaging to be compared with research imaging device. Followed by Tomo imaging No AE's	Standard CT n=1 Participants Standard of care CT imaging to be compared with research imaging device. Followed by Tomo imaging No AE's	Tomosynthesis n=1 Participants Tomosynthesis imaging to be compared to standard of care CT and X-ray No AEs
Number of Participants for Whom Tibia Injury Was Detected	1 participants	1 participants	1 participants

Adverse Events

Standard X-Ray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tomo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Uzenoff

Fujifilm Medical Systems, U.S.A., Inc.

Phone: (203) 602-3664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place