A Single-Arm, Open Label Clinical Study to Collect Safety Data on the Osteoprobe System When Used as a Measurement Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Active Life Scientific, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The Number of Participants With Reported Device Related Serious Adverse Events.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be greater than or equal to 22 years of age;
- •Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- •If female and of child-bearing potential, must have a negative pregnancy status.
Exclusion Criteria
- •Active skin infection at the procedure site as identified during a SOC physical examination.
- •Subject-reported or known systemic infection;
- •Subject-reported or known allergy to local anesthetic;
- •Subject-reported or known allergy to stainless steel or nickel materials;
- •Subject-reported or known current use of systemic antibiotics, or topical antibiotics administered to the procedure site;
- •Subject-reported or known history of needle phobia;
- •Significant soft tissue at the procedure site which would preclude use of the OsteoProbe in the judgement of the Investigator;
- •Known instance of hardware in the tibia that is intended to be measured based on radiographic imaging;
- •Known instance of a previous or current fracture in the tibia that is intended to be measured based on radiographic imaging;
- •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;
- •Are known to be currently abusing drugs or alcohol or have a known history of the same within the last 12 months;
- •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;
- •Are currently a prisoner;
- •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:
- •Regional or systemic pain syndromes
- •Radicular pain syndromes
- •Chronic or intermittent leg pain
- •Migraine headaches
Outcomes
Primary Outcomes
The Number of Participants With Reported Device Related Serious Adverse Events.
Time Frame: 30-day follow up visit
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.
The Number of Participants With Reported Device Related Serious Adverse Events.
Time Frame: Procedure
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.
The Number of Participants With Reported Device Related Serious Adverse Events.
Time Frame: 1-day follow up visit
The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.
The Number of Participants With Reported Device Related Serious Adverse Events.
Time Frame: 7-day follow up visit
The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.
Secondary Outcomes
- Number of Participants With Adverse Events(Procedure through day 30)
- Number of Participants With Serious Adverse Events(Procedure through day 30)
- Unanticipated Adverse Device Effects (UADE)(Procedure through day 30)
- NRS Pain Scores(Post-procedure, 1-day, 7-day and 30-day follow up visits)
- BMSi Scores(Procedure)
- Number of Participants With Device-related Adverse Events(Procedure through day 30)