Bone TumorEPIOSNCT07325578
U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures
A study testing Percutaneous procedure in the MSK structures of the pelvis and/or the spine in people with Bone Tumor and Osteoporosis, run by Precision IO Group at 3 sites in United States.
Trial summary
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Bone Tumor, Osteoporosis, Traumatic Fracture
- What is being tested?
- Percutaneous procedure in the MSK structures of the pelvis and/or the spine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥22 years old,
- Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,
- Patients who have signed an IRB-approved informed consent form
- Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure
- Inclusion criteria linked to the freehand procedure have been discussed and validated
Who cannot join
- Patients with contraindication to undergo general anesthesia,
- Patients unable to maintain appropriate breathing control,
- Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated
- Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,
- Pregnant or breast-feeding women,
- Patients subject to a legal protection measure,
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- Patients already participating in another conflicting interventional clinical study,
- Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.
- Patients having a coagulation abnormalities or bleeding disorder
- Patients having an active infection on the day of intervention
- Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach
- Exclusion criteria linked to the freehand procedure have been discussed and validated
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Jordan Tasse, MD, 847-422-3414 ext. +1, Jordan_C_Tasse@rush.edu
Rehan Riaz, MD
- Recruiting
Baptist Hospital Of Miami, Inc
Miami, Florida, 33176
Gina Landinez, MD, 786-596-2373 ext. +1, Gina.Landinez@baptisthealth.net
Gina Landinez, MD
- Recruiting
UC San Diego
San Diego, California, 92093
Sean Tutton, MD, 858-249-0460 ext. +1, stutton@health.ucsd.edu
About this study
Official title: Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
The main question is the determination of the rate of feasible procedures assisted by the Epione device
Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:
- The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate
- Additional CT or CBCT scans during the procedure.
- Conditions
- Bone Tumor, Osteoporosis, Traumatic Fracture
- Being tested
- Percutaneous procedure in the MSK structures of the pelvis and/or the spine
- Keywords
- percutaneous procedure, robot assistance, bone procedure
- Medical subject headings
- Bone Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous procedure in the MSK structures of the pelvis and/or the spineDevice
The introducer placement is performed with the Epione device.
| Study group | Role | What they receive |
|---|---|---|
| CT guidance | Experimental | The procedure is performed under CT guidance. Receives: Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine |
| CBCT guidance | Experimental | The procedure is performed under CBCT guidance. Receives: Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
Rate of successful insertions of the introducer with the assistance of the Epione device.
Measured: 5 months
Secondary outcomes (2)
Safety Adverse Event
Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s))
Measured: 6 months
Accuracy
Lateral and 3D deviations, being the distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory (lateral deviation) and the distance (mm) between the tip of the inserted introducer in its final position and the tip of the first planned trajectory (3D deviation).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start28 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision IO Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICUREsearch, Endpoint, LLC
- Responsible party
- Sponsor
- Investigators
- Sean Tutton, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325578
- Sponsor's protocol ID
- CA-BO-CIP-0130
- Acronym
- EPIOS
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Age, Sex, Ethnicity, Race will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy
- ClinicalTrials.gov ID
- NCT07325578
- Acronym / sponsor ID
- EPIOS / CA-BO-CIP-0130
- Conditions
- Bone Tumor, Osteoporosis, Traumatic Fracture
- Keywords
- percutaneous procedure, robot assistance, bone procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Precision IO GroupIndustry (pharma, biotech, devices)
- Collaborators
- ICUREsearch, Endpoint, LLC
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
The main question is the determination of the rate of feasible procedures assisted by the Epione device
Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:
- The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate
- Additional CT or CBCT scans during the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT guidance | Experimental | Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spineThe procedure is performed under CT guidance. |
| CBCT guidance | Experimental | Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spineThe procedure is performed under CBCT guidance. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥22 years old,
- Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,
- Patients who have signed an IRB-approved informed consent form
- Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure
- Inclusion criteria linked to the freehand procedure have been discussed and validated
Key exclusion criteria (12 listed)
- Patients with contraindication to undergo general anesthesia,
- Patients unable to maintain appropriate breathing control,
- Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated
- Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,
- Pregnant or breast-feeding women,
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 |
|---|---|---|
| Percutaneous procedure in the MSK structures of the pelvis and/or the spineThe introducer placement is performed with the Epione device. | Device | CBCT guidance, CT guidance |
Primary outcome
Feasability
Time frame: 5 months
Rate of successful insertions of the introducer with the assistance of the Epione device.
2 secondary outcomes
Safety Adverse Event
Time frame: 6 months
Accuracy
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Age, Sex, Ethnicity, Race will be shared
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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.
Sean Tutton, MD principal investigator
UC San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous procedure in the MSK structures of the pelvis and/or the spine in people with Bone Tumor and Osteoporosis, run by Precision IO Group at 3 sites 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Meyers (305 731-2901 ext. +1, clinical.department@quantumsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability (time frame: 5 months). 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 20 Jul 2026.