NCT07325578

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

December 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

April 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

December 19, 2025

Last Update Submit

April 30, 2026

Conditions

Bone TumorOsteoporosisTraumatic Fracture

Keywords

percutaneous procedurerobot assistancebone procedure

Outcome Measures

Primary Outcomes (1)

  • Feasability

    Rate of successful insertions of the introducer with the assistance of the Epione device.

    5 months

Secondary Outcomes (2)

  • Safety Adverse Event

    6 months

  • Accuracy

    5 months

Study Arms (2)

CT guidance

EXPERIMENTAL

The procedure is performed under CT guidance.

Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine

CBCT guidance

EXPERIMENTAL

The procedure is performed under CBCT guidance.

Device: Percutaneous procedure in the MSK structures of the pelvis and/or the spine

Interventions

Percutaneous procedure in the MSK structures of the pelvis and/or the spineDEVICE

The introducer placement is performed with the Epione device.

CBCT guidanceCT guidance

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC San Diego

San Diego, California, 92093, United States

NOT YET RECRUITING

Baptist Hospital Of Miami, Inc

Miami, Florida, 33176, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Bone NeoplasmsOsteoporosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sean Tutton, MD

    UC San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia Messner

CONTACT

305 731-2901clinical.department@quantumsurgical.com

Marion Chassouant

CONTACT

448 19 40 50clinical.department@quantumsurgical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 8, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Age, Sex, Ethnicity, Race will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
by the end of the study
Access Criteria
everyone, they will be described in the report and publication

Locations

US(3)