Testimonials & Publications

Pr. Alban Denys – CHUV Lausanne, Switzerland

“CT-Navigation™ is used in my centre on a daily basis. It is particularly useful for out-of-plane access to deeply located lesions like adrenal tumors or liver lesions located under the dome. It is extremely user-friendly, easy to manage and simple both for the nurses and technicians in my angio lab and for residents rotating every 3-6 months. It has a great potential in the future for complex treatment planning in ablation procedures.“

Pr. Eric de Kerviler – APHP, Saint-Louis Hospital, France

“The holy grail in CT-guided procedures is to be able to reach any target lesion quickly and safely. Imactis’s CT-Navigation™ is a very powerful tool as it allows to plan complex trajectories and determine the entry point of the needle simultaneously. Intra-procedurally, the system is particularly efficient in difficult cases for which a double oblique trajectory is mandatory, even with target near the diaphragm. For every procedure, the system also reduces the number of control scans, and therefore maintains the radiation as low a dose as possible for both patients and radiologists. Allowing unlimited trajectories, Imactis opens new horizons, making reachable the unreachable targets“

Dr. Christian Sengel – Grenoble Hospital, France

“I personally used CT-Navigation™ assistance for over 5 years. I am an interventional radiologist specialized in pelvic and abdominal cancer treatment. For me, the system’s benefits are with percutaneous thermal ablations (radiofrequency, microwave and cryoablation) particularly for both deep and mobile nodules, like nodules in segment 7 (Couinaud). CT-Navigation™ considerably increases your accuracy in the first punctions. This also means reducing the number of CT scan controls, without using fluoroscanner, seeing fewer complications in the trajectory, and delivering treatment with more precision (therefore reducing recurrences). Even though in theory the system does not take internal breathing movements into account, the radiologist can move into the acquired volume dynamically, see the shifting of the image of interest and easily extrapolate to obtain the exact path to the target.“

Pr. Ivan Bricault – Grenoble Hospital, France

“CT-Navigation™ provides valuable assistance by increasing the accuracy and reducing the number of control scans. It would be difficult for me to imagine completing certain complex interventions (double-oblique trajectories for example) without the safety and comfort provided by the Imactis CT-Navigation™ station. The system’s ease-of-use has also helped less experienced radiologists to become acquainted with CT-guided interventions; these radiologists would have been reluctant to perform procedures without the assistance of navigation.”

Clinical study CT-NAV II

Clinical study CT-NAV II is a multicentric, comparative, prospective and randomized clinical study. It took place in 9 French publics hospitals, more than 450 patients were enrolled.
The aim of this trial is to evaluate the clinical benefit of the navigation system by comparing the results obtained in the navigation-assisted group with those obtained in the conventional group during CT-guided procedures.
Three criterias are used:

• Safety: The number of AEs that are considered to be major.
• Efficacy: The number of targets reached
• Performance: The number of control scans acquired during the needle insertion.

Publication of study protocol
Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle, F. Patat, E. De Kerviler, C. Hughes, M. Medici, J. Ghelfi, A. Mounier and I. Bricault.

Trials, July, 6, 2017.

CT guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (FICS)

Objective
To evaluate electromagnetic navigation system (ENS) for percutaneous fixation by internal cemented screw (FICS) under CT guidance.

Outcomes
Mean duration of FICS procedures was 111 ± 51 min. Mean post-procedure hospitalization length was 2.1 days. Technical success was achieved in 48 cases (96%) with a total of 76 screws inserted. Mean distance p, mean distance d, and mean angle θ were respectively 8.0 ± 4.5 mm, 7.5 ± 4.4 mm, and 5.4 ± 2°. Angle θ accuracy was higher for screws with a craniocaudal angulation of less than 20° (4.4° vs 6.4°, p = 0.02). The mean number of CT acquisitions during procedures was 6.4 ± 3.0. The mean dose length product was 1524 ± 953 mGy cm and the mean dose area product was 12 ± 8 Gy cm2. Five complications occurred in 4 patients.

Key Points

• ENS-assisted CT enables screw insertion in the pelvic ring and femoral neck, with a wide range of trajectories, even when a significant craniocaudal angulation is required.
• ENS-assisted CT can be used as an alternative to CBCT guidance for percutaneous fixation by internal cemented screw.
• ENS-assisted CT provides high technical success rate with excellent placement accuracy.

Publication 
CT guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (FICS). B. Moulin, L. Tselikas, T. De Baere, F. Varin, A. Abed, L. Debays, C. Bardoulat, A. Hakime, C. Teriitehau, F. Deschamps

European Radiology, September 2, 2019

Use of an Electromagnetic Navigation System on a Phantom as a Training Simulator for CT-Guided Procedures

Description of the problem
CT-guided procedures are an essential part of the clinical work at many hospitals across the United States and throughout the world. CT guidance is used for biopsies, abscess drainages, and ablations. Currently, radiology residents and fellows acquire their CT procedural skills on real patients. Both diagnostic and interventional radiologists perform some of these procedures, and therefore the experience and skill set in performing these procedures can vary widely.

Although CT-guided procedures have been used to successfully diagnose and treat a wide range of pathologies, it is at the expense of increased radiation exposure to both operators and patients. Limiting radiation exposure in interventional radiology has been an important discussion point, and societies such as the Cardiovascular and Interventional Radiological Society of Europe and the Society of Interventional Radiology have provided strong recommendations in an effort to reduce excessive radiation exposure.

Over the past several years, multiple new navigational tools have entered the market, helping guide fully trained interventional radiologists during CT-guided procedures. Using fiducials and optical or electromagnetic tracking, these tools create a “global positioning system” of the internal organs and can allow the needle to be tracked in real time. These navigational tools also allow a simulated CT experience, enabling a phantom to be imaged on a CT scanner and a biopsy procedure simulated at a location and time separate from the planning CT scan, without the need for additional radiation to the patient and operator.

Although navigational systems may offer an alternative for training and performing CT-guided procedures in the future for both interventional and noninterventional radiologists, little is known about the difficulty and the amount of procedural experience needed to successfully use these navigational systems.

The purpose of this study was to compare the diagnostic and interventional radiologist trainee’s CT-guided procedural skills using an electromagnetic navigational guidance system (EMN, Imactis, La Tronche, France) that mimics a CT-guided biopsy and determine whether prior experience predicts technical success using these systems.

Methods
This prospective study was reviewed and exempted by the institutional review board. A total of 19 fellows (12 interventional fellows and 7 diagnostic fellows) participated in the study. The study was performed 3 months into the fellows’ training (September 2014).

The study consisted of a skills test that simulated a CT-guided procedure. The simulation consisted of two parts: One part allowed targeting of three progressively difficult lesions on a phantom using standard manual/conventional skills. A second part tested targeting of the same lesions using an EMN.

Publication of study protocol
Use of an Electromagnetic Navigation System on a Phantom as a Training Simulator for CT-Guided Procedures, Yadiel Sánchez, BA, Dmitry S. Trifanov, MD, Taj M. Kattapuram, MD, Haiyang Tao, MD, PhD, Anand M. Prabhakar, MD, MBA, Ronald S. Arellano, MD, Raul N. Uppot, MD

Published on JACR (Journal of the American College of Radiology), June 2017, Volume 14, Issue 6, Pages 795–799

Evaluation of a Computed Assisted Medical Intervention (CAMI) in scientific autopsy

This study is the first step of an ambitious project to use pre-operative post-mortem computed tomography (CT) imaging and a Computer Assisted Medical intervention (CAMI) device for guidance of targeted biopsy in an effort to demonstrate the continuing scientific value of the autopsy in clinical practice and therefore increase the number of autopsies carried out.

The main objectives are :

• Build the first step of the vision associating Computed Assisted Medical Interventions and forensic science.
• Show the possibility to perform mini-invasive autopsy in the autopsy room without a CT-scan in it with a radiology interventional tool.
• Show the limitations and the advantages of the device in this use.
• Show the difficulties linked to the state of the corpse.
• Draw conclusions on the possibilities to improve this protocol, including a per-operative tool, and continue research in this way.

Publication of study protocol
Evaluation of a Computed Assisted Medical Intervention (CAMI) systems in scientific autopsy, Grenier F., Voros S., Scolan V., Paysant F., Boutonnat J., Bricault I., Moreau-Gaudry A.

Journal of Forensic Radiology and Imaging, Volume 11, December 2017, Pages 6-11

Perioperative outcomes and mid-term results of radiofrequency ablation and partial nephrectomy in indications of renal tumor treatment and imperative nephron-sparing procedure

Objective
To compare morbidity, oncological and functional outcomes of percutaneous radiofrequency ablation (RFA) and partial nephrectomy in indications of renal tumor treatment with imperative nephron-sparing procedure.

Results
Thirty-six PN and 14 RFA were performed. RFA patients were older (79.2 vs. 62.5 years old), had a higher ASA score (3 vs. 2), a lower RENAL score (6 vs. 7.5) and a lower rate of tumor on solitary kidney or bilateral tumors (P = 0.009). Overall complications (29.4% vs. 6.3%), transfusions (20.6% vs. 0) and longer hospital stay (9 vs. 3 days) were more likely to occur in the NP group. During a median follow-up of 22 months (4.3–53.7), eGFR decrease was similar between the two groups (P = 0.34). On multivariate analysis, PN was associated with an increased occurrence of overall complications (OR = 14.09, P = 0.02) but with a similar eGFR decrease. No patient died.

Conclusion
For patients with an indication of treatment of renal tumor and imperative nephron-sparing procedure, RFA seems to provide low morbidity and comparable functional outcomes as partial nephrectomy. Our limited follow-up does not permit to conclude on oncologic data.

Publication
Perioperative outcomes and mid-term results of radiofrequency ablation and partial nephrectomy in indications of renal tumor treatment and imperative nephron-sparing procedure, V.Arnoux, J.-L. Descotes, C. Sengel, N. Terrier, J.-J.Rambeaud, J.-A. Long.

Published on Elsevier, “Progrès en Urologie”, Volume 23, Issue 2, February 2013, Pages 99-104

Percutaneous osteosynthesis and cementoplasty for stabilization of malignant pathologic fractures of the proximal femur.

Purpose

To retrospectively evaluate the outcome of patients who underwent radiological percutaneous osteosynthesis and cementoplasty (RPOC) for stabilization of malignant pathological fracture of the proximal femur.

Materials and methods

The clinical files of 12 patients who underwent RPOC for stabilization of malignant pathological fracture of the proximal femur were reviewed. There were 9 men and 3 women with a mean age of 56 years ± 13 (SD) (range: 35–82 years). All patients had metastases of proximal femur and a high fracture risk (Mirels score ≥ 8) and were not eligible for surgical stabilization. The primary endpoint was the occurrence of a fracture after RPOC. Secondary endpoints were the procedure time, early complications of RPOC, pain reduction as assessed using a visual analog scale (VAS) and duration of hospital stay.

Results

No patients treated with RPOC had a fracture during a mean follow-up time of 382 days ± 274 (SD) (range: 11–815 days). RPOC was performed under general (n = 10) or locoregional (n = 2) anesthesia. The average duration of the procedure was 95 min ± 17 (SD) (range: 73–121 min). The technical success rate was 100%. All patients were able to walk on the day following RPOC. The average duration of hospital stay was 4 days ± 3 (SD) (range: 2–10 days). No major complication occurred. One patient complained of hypoesthesia in the lateral thigh. For symptomatic patients (n = 7), VAS score decreased from 6.8 ± 1.2 (SD) (range: 5–9) before treatment, to 2.3 ± 1.1 (SD) (range: 1–4) one month later.

IMACTIS Ct-Navigation™ was used for needle positionning.

Conclusion

Preventive RPOC for pathological fracture of the proximal femur is a reliable alternative for cancer patients who are not candidates for surgical stabilization. Studies involving more patients are needed to confirm our preliminary experience.

Publication

Percutaneous osteosynthesis and cementoplasty for stabilization of malignant pathologic fractures of the proximal femur, E. Mavrovi, J.-B. Pialat, H. Beji, A.-C.Kalenderian, G. Vaz, B. Richioud

Published on Elsevier, Diagnostic and Interventional Imaging, Volume 98, Issue 6, June 2017, Pages 483-489

Clinical study CT-NAV I – Increased accuracy and fewer controls

IMACTIS CT-Navigation™ was successfully validated during a comparative, prospective, randomized clinical study on 120 patients at the Grenoble University Hospital on various procedures (drainage, biopsy, tumor ablation, infiltration, sympathicolysis).

The clinical study shows, that when compared to conventional procedures, the use of IMACTIS leads to:

• Increased accuracy (gain in distance and angle accuracy higher than 50%)
• Fewer controls are necessary to reach the target.

Publication

Computer assisted electromagnetic navigation improves accuracy in computed tomography guided interventions: A prospective randomized clinical trial. P. Durand, A. Moreau-Gaudry, A. Silvent, J. Frandon, E. Chipon, M. Medici, I. Bricault.

PLoS One, March, 15, 2017.