EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy (EPIBONE)

April 18, 2024 updated by: Quantum Surgical

Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures A Prospective Study on Feasibility, Safety and Accuracy

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient ≥18 years,
  2. Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
  3. Patient who has signed an informed consent form,
  4. Patient covered by a social security system,
  5. Patient who has already been included in the EPIBONE study but eligible for percutaneous procedure of a new musculoskeletal disorder location.

Non-inclusion Criteria:

  1. Patient with contraindication to general anaesthesia,
  2. Patient undergoing a procedure without appropriate breathing control,
  3. Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
  4. Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
  5. Pregnant or breast-feeding women,
  6. Patient under legal protection (tutorship, guardianship, …),
  7. Patient already participating in another interventional clinical study.

In conventional interventional radiology procedures, pregnancy status is based on patient declaration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Procedure: CT-guided bone percutaneous procedure
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures (thermal ablation, bone consolidation, biopsy procedures).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful instrument insertion with the EPIONE device.
Time Frame: During procedure
Assessment of the feasibility of the EPIONE robotic system assistance for bone percutaneous procedures based on a definition of conversion to manual technique
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quantum Surgical

Investigators

  • Principal Investigator: Thierry DE BAERE, Gustave Roussy Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-BO-CIP-0060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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