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Completed

NCT Number: NCT01056432

Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

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.

Completed

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Smart Medical Center

Philadelphia, Pennsylvania, 19115, United States

About this study

The specific aims of this clinical study are:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Primary outcomes

  1. To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Acronym: BUSS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2010
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.