Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Artann Laboratories

Status: Completed

Conditions: Osteoporosis

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01056432

BUSS-02

2R44AG017400 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

Full description

The specific aims of this clinical study are:

1. To optimize the data collection technique and establish an examination procedure;
2. To collect data necessary for assessing the performance of BUSS sensors;
3. To evaluate the probe ergonomic design and participant tolerance to probe application;
4. To assess the clinical suitability of the software interface in data collection;
5. To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;
6. To evaluate BUSS performance including ease of use and consistency.

Enrollment: 100 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available

Exclusion criteria

Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index >34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids