Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01056432
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2010-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
Sponsor:
Artann Laboratories
Organization:
Study Overview
Official Title:
Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUSS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R44AG017400 | NIH | None | https://reporter.nih.gov/quic… | View |