Trial Outcomes & Findings for Open Label Study Using OsteoProbe System (NCT NCT04628221)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Procedure

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	OsteoProbe System 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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OsteoProbe System n=40 Participants 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.
Age, Continuous	45.95 years STANDARD_DEVIATION 14.41 • n=40 Participants
Sex: Female, Male Female	30 Participants n=40 Participants
Sex: Female, Male Male	10 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
The Number of Participants With Reported Device Related Serious Adverse Events.	0 Participants

PRIMARY outcome

Timeframe: 1-day follow up visit

The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
The Number of Participants With Reported Device Related Serious Adverse Events.	0 Participants

PRIMARY outcome

Timeframe: 7-day follow up visit

The incidence of device-related serious adverse events (SAEs) in subjects evaluated with the OsteoProbe System.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
The Number of Participants With Reported Device Related Serious Adverse Events.	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
The Number of Participants With Reported Device Related Serious Adverse Events.	0 Participants

SECONDARY outcome

Timeframe: Post-procedure, 1-day, 7-day and 30-day follow up visits

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).

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
NRS Pain Scores	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Procedure

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.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
BMSi Scores	77.35 score Standard Deviation 8.24

SECONDARY outcome

Timeframe: Procedure through day 30

The number of participants who experienced an adverse event.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
Number of Participants With Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Procedure through day 30

The number of participants who experienced an device-related adverse event.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
Number of Participants With Device-related Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Procedure through day 30

The number of participants who experienced a Serious adverse event.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
Number of Participants With Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Procedure through day 30

The number of participants who experienced a Unanticipated adverse device effects.

Outcome measures

Outcome measures
Measure	OsteoProbe System n=40 Participants 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.
Unanticipated Adverse Device Effects (UADE)	0 Participants

Adverse Events

OsteoProbe System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OsteoProbe System n=40 participants at risk 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.
Musculoskeletal and connective tissue disorders Joint Pain	2.5% 1/40 • Number of events 1 • 30 days

Additional Information

Nicole Harris

MCRA, LLC

Phone: 202-552-5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place