UnknownNot Applicable

Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study

United States140 participantsStarted 2018-12-20

Plain-language summary

The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Are adults aged 18 years or older;
✓. Are able and willing to comply with study procedures; and
✓. Are able and willing to provide written informed consent to participate in this study.

Exclusion criteria

✕. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
✕. Have had known prior trauma in either wrist.
✕. Are adults aged 18 years or older;
✕. Have a confirmed or suspected distal radius or scaphoid wrist fracture;
✕. Have completed an X-ray imaging exam per standard of care;
✕. Have a standard of care (SOC) CT or MRI exam ordered;
✕. Are able and willing to complete DTS imaging exam (if not already completed);
✕. Are able and willing to comply with study procedures; and

What they're measuring

Number of X-ray Images

Timeframe: 1 year

Number of DTS images

Timeframe: 1 year

Number of CT (or MRI) images

Timeframe: 1 year

Trial details

NCT IDNCT03856450

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-01

Contact for this trial

Mary Dooley

(215)-294-9650 Mary.Dooley@uphs.upenn.edu

View on ClinicalTrials.gov More Distal Radius Fracture trials