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Clinical Trials/NCT01056432
NCT01056432
Completed
Not Applicable

Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Artann Laboratories1 site in 1 country100 target enrollmentStarted: January 2010Last updated:
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ConditionsOsteoporosis

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Artann Laboratories
Enrollment
100
Locations
1
Primary Endpoint
To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
21 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Artann Laboratories
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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