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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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