Open Label Study Using OsteoProbe System (OP)

A Single-Arm, Open Label Clinical Study to Collect Safety Data on the Osteoprobe System When Used as a Measurement Tool

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effects in the Use of the OsteoProbe System
• Intervention / Treatment: Device: OsteoProbe System

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Reported Device Related Serious Adverse Events.	The number of participants who experienced device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System, per potential risks in the protocol.	Procedure
The Number of Participants With Reported Device Related Serious Adverse Events.	The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.	1-day follow up visit
The Number of Participants With Reported Device Related Serious Adverse Events.	The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.	7-day follow up visit
The Number of Participants With Reported Device Related Serious Adverse Events.	The number of participants who experienced device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System, per potential risks in the protocol.	30-day follow up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Scores	The Numeric Rating Scale (NRS) is a continuous scale comprised of a line, with an eleven point numeric range (0 to 10) anchored by 2 verbal descriptors, one for each symptom extreme. The 0 mark corresponds to 'no pain', while the 10 mark corresponds to 'worse pain possible'. Therefore, higher scores indicate greater pain intensity. At all follow-up time points (post-procedure, Day 1, Day 7 , and Day 30), average was taken compared to baseline (Pre-Procedure).	Post-procedure, 1-day, 7-day and 30-day follow up visits
BMSi Scores	BSMi Score is an output measure by the OsteoProbe device to measure bone tissue's resistance to microindentation which can be positively correlated with bone tissue quality.	Procedure
Number of Participants With Adverse Events	The number of participants who experienced an adverse event.	Procedure through day 30
Number of Participants With Device-related Adverse Events	The number of participants who experienced an device-related adverse event.	Procedure through day 30
Number of Participants With Serious Adverse Events	The number of participants who experienced a Serious adverse event.	Procedure through day 30
Unanticipated Adverse Device Effects (UADE)	The number of participants who experienced a Unanticipated adverse device effects.	Procedure through day 30

Collaborators and Investigators

• Sponsor: Active Life Scientific, Inc.
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OP2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes