NCT01056432

Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Artann Laboratories · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Osteoporosis

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-01-26
• Last updated: 2014-03-31

Locations

1 site across 1 country: United States