Open Label Study Using OsteoProbe System

NCT ID: NCT04628221

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2020-12-30

Brief Summary

Prospective, Single Center, Open Label Clinical Study. The purpose of the study is to collect safety data associated with the use of the OsteoProbe System. Study Duration is expected to take approximately 3 months from first subject enrolled to the last follow-up visit.

Conditions

Adverse Effects in the Use of the OsteoProbe System

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

OsteoProbe System

The OsteoProbe® System ("OsteoProbe") is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Be greater than or equal to 22 years of age;

2. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

3. If female and of child-bearing potential, must have a negative pregnancy status.

Exclusion Criteria

1. Active skin infection at the procedure site as identified during a SOC physical examination.

2. Subject-reported or known systemic infection;

3. Subject-reported or known allergy to local anesthetic;

4. Subject-reported or known allergy to stainless steel or nickel materials;

5. Subject-reported or known current use of systemic antibiotics, or topical antibiotics administered to the procedure site;

6. Subject-reported or known history of needle phobia;

7. Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the judgement of the Investigator;

8. Known instance of hardware in the tibia that is intended to be measured based on radiographic imaging;

9. Known instance of a previous or current fracture in the tibia that is intended to be measured based on radiographic imaging;

10. Are known to be actively participating or known to have participated in another clinical investigation for which they received an investigational product (including but not limited to a drug or vaccine) within the last 90 days, or reports that they intend to participate in another clinical investigation during the course of the study;

11. Are known to be currently abusing drugs or alcohol or have a known history of the same within the last 12 months;

12. Have any known or subject reported mental or psychological disorders that, in the judgement of the Investigator, would impair their ability to accurately complete the NRS Pain Score surveys;

13. Are currently a prisoner;

14. Have a condition which, in the judgement of the Investigator, would preclude adequate evaluation of the device's safety and performance. Conditions include but are not limited to:

1. Regional or systemic pain syndromes

2. Radicular pain syndromes

3. Chronic or intermittent leg pain

4. Migraine headaches

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

Active Life Scientific, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Meridian Clinical Research, LLC.

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OP2020

Identifier Type: -

Identifier Source: org_study_id