IBEX Trueview® Study, version 1.0

• Research type

  Research Study

• Full title

  Evaluation of IBEX Trueview System to assess its effectiveness in producing image quality and bone mineral density measurement equivalent to conventional radiology

• IRAS ID

  255317

• Contact name

  Amar Rangan

• Contact email

  a.rangan@btopenworld.com

• Sponsor organisation

  IBEX Innovations Ltd.

• Duration of Study in the UK

  0 years, 5 months, 0 days

• Research summary

  Digital radiography is widely used as a way of obtaining images of the internal structures of the body using X-rays. A major drawback of using X-rays is that they can be scattered by thicker body parts. This scatter significantly reduces image quality and is currently dealt with by using a physical anti-scatter grid (ASG) which prevents scattered X-rays from reaching the X-ray detector/camera.

  Anti-scatter grids also absorb a portion of the direct X-rays required to form a useful image and so the patient dose needs to be increased to compensate. Removing the need for an ASG would potentially allow lower dose examinations to take place.

  Additionally, current digital radiography systems offer no way of extracting numerical information about the composition of the image, meaning that a lot of potentially useful diagnostic information is lost.

  Proposed clinical investigation
  IBEX Innovations Limited (IBEX), a local high-technology business based in Sedgefield, has developed a novel solution that offers the potential to remove the effects of scattered X-rays without the need for an ASG. The technology also enables the extraction of bone health information which will be demonstrated in Phase 2 of the study.

  IBEX and South Tees Hospitals NHS Trust are planning to demonstrate the value to patients of this new technology by undertaking a study at the James Cook University Hospital.

  There are two main aims of the proposed study:
  Phase 1 - To demonstrate that the Trueview® technology generates X-ray images to at least the same quality as an existing X-ray system
  Phase 2 - To demonstrate that Trueview® generates a measure of bone health to the same accuracy as a dedicated DEXA system

  We are aiming to recruit about 60 patients for phase 1 and about 130 for phase 2 from the orthopaedic outpatients’ clinics and rheumatology department respectively.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  18/NE/0368

• Date of REC Opinion

  27 Dec 2018

• REC opinion

  Further Information Favourable Opinion