Bone UltraSonic Scanner (BUSS) Clinical Optimization Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01056432
First received: January 24, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056432

Locations
United States, Pennsylvania
Health Smart Medical Center
Philadelphia, Pennsylvania, United States, 19115
Sponsors and Collaborators
Artann Laboratories
Investigators
Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories
  More Information

No publications provided

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01056432     History of Changes
Other Study ID Numbers: BUSS-02, 2R44AG017400
Study First Received: January 24, 2010
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Artann Laboratories:
osteoporosis, bone fracture risk, bone ultrasonometry

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014