Adverse Effects in the Use of the OsteoProbe SystemOPNCT04628221
Open Label Study Using OsteoProbe System
A study testing OsteoProbe System in people with Adverse Effects in the Use of the OsteoProbe System, run by Active Life Scientific, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects in the Use of the OsteoProbe System
- What is being tested?
- OsteoProbe System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Meridian Clinical Research, LLC.
Omaha, Nebraska, 68134
About this study
Official title: 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.
- Being tested
- OsteoProbe System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoProbe SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30-day follow up visit
Secondary outcomes (6)
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).
Measured: 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.
Measured: Procedure
Number of Participants With Adverse Events
The number of participants who experienced an adverse event.
Measured: Procedure through day 30
Number of Participants With Device-related Adverse Events
The number of participants who experienced an device-related adverse event.
Measured: Procedure through day 30
Number of Participants With Serious Adverse Events
The number of participants who experienced a Serious adverse event.
Measured: Procedure through day 30
Unanticipated Adverse Device Effects (UADE)
The number of participants who experienced a Unanticipated adverse device effects.
Measured: Procedure through day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start31 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse Effects in the Use of the OsteoProbe SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Active Life Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628221
- Sponsor's protocol ID
- OP2020
- Acronym
- OP
- Status last verified
- Mar 2021
- First submitted
- 2 Nov 2020
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open Label Clinical Study to Collect Safety Data on the Osteoprobe System When Used as a Measurement Tool
- ClinicalTrials.gov ID
- NCT04628221
- Acronym / sponsor ID
- OP / OP2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Active Life Scientific, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteoProbe SystemThe 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. | Device | – |
Primary outcome
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.
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.
6 secondary outcomes
NRS Pain Scores
Time frame: Post-procedure, 1-day, 7-day and 30-day follow up visits
BMSi Scores
Time frame: Procedure
Number of Participants With Adverse Events
Time frame: Procedure through day 30
Number of Participants With Device-related Adverse Events
Time frame: Procedure through day 30
Number of Participants With Serious Adverse Events
Time frame: Procedure through day 30
Unanticipated Adverse Device Effects (UADE)
Time frame: Procedure through day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsteoProbe System in people with Adverse Effects in the Use of the OsteoProbe System, run by Active Life Scientific, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With Reported Device Related Serious Adverse Events. (time frame: Procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021; AzTrials last refreshed its copy on 28 Oct 2026.