Cancer AbdomenSaFENCT05529979
Epione® Post-Market Clinical Follow-up Study
An observational study of Cancer Abdomen, run by Quantum Surgical at 1 site in France.
Trial summary
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Abdomen
- What is being tested?
- EPIONE® CT-Guided Percutaneous procedures
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2022to 27 Apr 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.
Who may be able to join
- Patient >18 years old,
- Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient with a confirmed non-opposition.
Who cannot join
- Patient unable to undergo general anesthesia,
- Pregnant or breast-feeding females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
Read the detailed description
The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.
The objectives are:
- to evaluate the technical success of the device
- to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device
55 patients are planned in this post-market study.
- Conditions
- Cancer Abdomen
- Being tested
- EPIONE® CT-Guided Percutaneous procedures
- Keywords
- Percutaneous, CT-guided, Ablation, Biopsy, Abscess Drainage, Fiducial Placement, Abdomen, Liver, Kidney, Robotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIONE® CT-Guided Percutaneous proceduresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with the EPIONE® device | Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device Receives: Device: EPIONE® CT-Guided Percutaneous procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by patient)
Measured: Visit 2 - D0 The day of the intervention
Technical Success
Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by lesion)
Measured: Visit 2 - D0 The day of the intervention
Secondary outcomes (7)
Needle Placement Accuracy
accuracy of the needle placement: deviation between the planned and actual needle position once inserted
Measured: Visit 2 - D0 The day of the intervention
Number and Nature of Needle Adjustments to Reach the Target
Detail of the number/nature of adjustments performed after the initial insertion of the needle
Measured: Visit 2 - D0 The day of the intervention
Post-intervention Ablation Success
Minimal Ablation Margin(s) measure(s) if applicable (mm)
Measured: Until Visit 4 - Routine FU visit at 10 months
Local Tumor Recurrence
Evaluation of the local tumor progression following the ablation (if applicable)
Measured: Until Visit 4 - Routine FU visit at 10 months
Operator Satisfaction
5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied
Measured: Visit 2 - D0 The day of the intervention
Adverse Events Related to Device or Procedure
Safety of the device
Measured: Until Visit 4 - Routine FU visit at 10 months
Device Dysfunction
Evaluation of the device dysfunction
Measured: Visit 2 - D0 The day of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start28 Apr 2022
- Primary completion22 Feb 2023
- Study completion27 Apr 2024
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 Cancer AbdomenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baptiste BONNET, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529979
- Sponsor's protocol ID
- QS-NIS-G-H-2101
- Acronym
- SaFE
- Status last verified
- Aug 2025
- First submitted
- 7 Jun 2022
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
- ClinicalTrials.gov ID
- NCT05529979
- Acronym / sponsor ID
- SaFE / QS-NIS-G-H-2101
- Conditions
- Cancer Abdomen
- Keywords
- Percutaneous, CT-guided, Ablation, Biopsy, Abscess Drainage, Fiducial Placement, Abdomen, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Quantum SurgicalIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
Detailed description
The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.
The objectives are:
- to evaluate the technical success of the device
- to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device
55 patients are planned in this post-market study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with the EPIONE® device | – | Device: EPIONE® CT-Guided Percutaneous proceduresPatients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.
Key inclusion criteria (3 listed)
- Patient >18 years old,
- Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient with a confirmed non-opposition.
Key exclusion criteria (2 listed)
- Patient unable to undergo general anesthesia,
- Pregnant or breast-feeding females
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 |
|---|---|---|
| EPIONE® CT-Guided Percutaneous proceduresThe 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. | Device | Intervention with the EPIONE® device |
Primary outcome
Technical Success
Time frame: Visit 2 - D0 The day of the intervention
Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by patient)
Technical Success
Time frame: Visit 2 - D0 The day of the intervention
Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by lesion)
7 secondary outcomes
Needle Placement Accuracy
Time frame: Visit 2 - D0 The day of the intervention
Number and Nature of Needle Adjustments to Reach the Target
Time frame: Visit 2 - D0 The day of the intervention
Post-intervention Ablation Success
Time frame: Until Visit 4 - Routine FU visit at 10 months
Local Tumor Recurrence
Time frame: Until Visit 4 - Routine FU visit at 10 months
Operator Satisfaction
Time frame: Visit 2 - D0 The day of the intervention
Adverse Events Related to Device or Procedure
Time frame: Until Visit 4 - Routine FU visit at 10 months
Device Dysfunction
Time frame: Visit 2 - D0 The day of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer Abdomen
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
Baptiste BONNET, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Abdomen, run by Quantum Surgical at 1 site in France.
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 2 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 6 Jan 2026. 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 France. 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 6 Jan 2026). 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?
Technical Success (time frame: Visit 2 - D0 The day of the intervention). The study lists 2 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 6 Jan 2026.