## Protocol Section
### Identification Module
**NCT ID:** NCT05529979

**Acronym:** SAFE

**Brief Title:** Epione® Post-Market Clinical Follow-up Study

**Official Title:** Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

#### Organization Study ID Info
**ID:** QS-NIS-G-H-2101
#### Organization
**Class:** INDUSTRY
**Full Name:** Quantum Surgical
### Status Module
#### Completion Date
**Date:** 2023-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-08

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-02-22

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-21

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2022-09-07
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-07
**Study First Submit QC Date:** 2022-09-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Quantum Surgical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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

**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:

1. to evaluate the technical success of the device
2. 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 Module

**Conditions:**

- Cancer Abdomen

**Keywords:**

- Percutaneous

- CT-guided

- Ablation

- Biopsy

- Abscess Drainage

- Fiducial Placement

- Abdomen

- Liver

- Kidney

- Robotics

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 55

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device

**Intervention Names:**

- Device: EPIONE® CT-Guided Percutaneous procedures

**Label:** Intervention with the EPIONE® device

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention with the EPIONE® device

**Description:** 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.

**Name:** EPIONE® CT-Guided Percutaneous procedures

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Technical Success

**Time Frame:** through study completion up to 36 months

#### Secondary Outcomes

**Description:** accuracy of the needle placement: deviation between the planned and actual needle position once inserted

**Measure:** Needle placement accuracy

**Time Frame:** through study completion up to 36 months

**Description:** Detail of the number/nature of adjustments performed after the initial insertion of the needle

**Measure:** Number and nature of needle adjustments to reach the target

**Time Frame:** through study completion up to 36 months

**Description:** Minimal Ablation Margin(s) measure(s) if applicable (mm)

**Measure:** Post-intervention ablation success

**Time Frame:** through study completion up to 36 months

**Description:** Evaluation of the local tumor progression following the ablation (if applicable)

**Measure:** Local tumor recurrence

**Time Frame:** through study completion up to 36 months

**Description:** 5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied

**Measure:** Operator satisfaction

**Time Frame:** through study completion up to 36 months

**Description:** Safety of the device

**Measure:** Adverse Events related to device or procedure

**Time Frame:** through study completion up to 36 months

**Description:** Evaluation of the device dysfunction

**Measure:** Device dysfunction

**Time Frame:** through study completion up to 36 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Pregnant or breast-feeding females

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Villejuif

**Country:** France

**Facility:** Gustave Roussy Institut

**Zip:** 94000

#### Overall Officials

**Official 1:**

**Affiliation:** Gustave Roussy, Cancer Campus, Grand Paris

**Name:** THIERRY DE BAERE, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M37

- Name: Abscess

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
