Applications

Why not consider a micro-invasive approach
for the treatment of urologicl disorders?

SoracteLite is the EchoLaser Therapy treatment for urological disorders.

The name of the treatment contains, in a single word, a reference to the urologic application (“Soracte” is the name of an Italian mountain – also named in the opening lines of a poem by Horace – where there was a monastery where the monk Nonnoso, canonised and considered the protector of people with kidney diseases, lived) and “Lite”, which refers, on one hand, to the lightweight and micro-invasive nature of the treatment, and, on the other, to the therapeutic source (Light, therefore Laser).

The name SoracteLite differentiates the procedure performed with ECHOLASER (micro-invasiveness and multi-fibre approach in a single system) from other thermal ablation techniques.

Suitability

SoracteLite is the EchoLaser Therapy for the treatment of benign and malignant urological disorders, namely Benign Prostatic Hyperplasia (BPH), low-risk localised Prostate Cancer (PCa), and Kidney Cancer.

Benign Prostatic Hyperplasia

SoracteLite is indicated for patients suffering from Benign Prostatic Hyperplasia – a disease in which the increase in volume of the prostate gland causes a compression effect on the bladder floor and the urethral channel – who choose not to undergo surgical treatment.

Prostate Cancer

The gold standard treatments for patients with low-risk localised prostate cancer are surgery or radiotherapy, but the side effects of the treatment and possible patient comorbidities might hamper patients to allow these kind of approaches. In such cases, as stated by the Guidelines on Prostate Cancer issued by medical associations in the America and Europe, Focal Therapy may be a therapeutic option to offer to those patients, preferably recommended within a clinical trial setting. Among the available Focal Therapies, SoracteLite Transperineal Laser Ablation (TPLA) is a new Focal Laser Ablation (FLA) method that can destroy the lesion without causing the undesired side effects of radical therapies.

Kidney Cancer

As reported in the Guidelines issued by American and European urological associations, thermal ablative therapies have already been investigated as a possible alternative to surgery for the treatment of small and localized renal tumors (<4cm), with promising clinical results. This kind of approach is particularly suitable for patients at high surgical risk or with impaired renal function. In the field of minimally invasive therapies, SoracteLite applicators are considerably thinner than those used for radiofrequency ablation (RFA), microwave ablation (MWA) and cryoablation (CRA) devices currently on the market, ensuring an even less invasive approach, a key feature for patients at high risk of complications due to the presence of comorbidity (e.g. high risk of bleeding) or difficulty in technical access.

 

Performance

  • Shrinkage of the enlarged prostate tissue volume with consequent relief from localised symptoms in patients with BPH, thanks to the Laser Induced CytoReduction (LICR) process
  •  Complete ablation of malignant tumors (Prostate or Kidney Cancer) with a sufficient safety margin

When you hear the word laser in urology, you instantly may think of surgical lasers, like the green laser. These lasers are an important step forward for endoscopic, transurethral surgery of the prostate. However, SoracteLite does not employ surgical lasers. Indeed, it differs from them in wavelength and power (EchoLaser employs 1064 nm wavelength and extremely low powers, 3-5 W) and in its mode of action. Lastly and most importantly, SoracteLite uses a truly micro-invasive approach (transperineal vs transurethral) with extremely thin needles (21G).

What is it?

SoracteLite for the treatment of BPH

SoracteLite treatment consists in the percutaneous insertion of optical fibres (one or two fibres per lobe, depending on the basal volume of the prostate gland) via transperineal access, and the delivery of laser energy for several minutes, which heats the tissues until they are destroyed. This causes a progressive reduction in the volume of the prostate lobe (a volume reduction of at least 40% compared to the basal volume at one-year follow-up) and the subsequent disappearance of the symptoms. The planning of the treatment, the insertion of the needles and the monitoring are all carried out under ultrasound guidance.

To facilitate insertion, the system has a dedicated transrectal ultrasound probe multi-applicator Guiding System with the relative Planning Software that displays the guidelines and the estimated ablation area on the ultrasound system screen.

With just one SoracteLite session it is possible to obtain a significant and persistent reduction of the prostate gland volume and an improvement of localised symptoms, without changing the prostate’s physiology.

Clockwise:
1. TRT33 Esaote Probe with multi-fibre guiding system  / 2. Biopsy Software
3./4. TRT33 Esaote Probe equipped with the multi-fibre guiding system

SoracteLite for the treatment of PCa

SoracteLite TPLA (Transperineal Laser Ablation), a new Focal Laser Ablation method, consists in the percutaneous insertion of optical fibres via transperineal access under MRI-US Fusion Imaging guidance, and the delivery of laser energy for several minutes to heat the tissues until they are completely destroyed with a sufficient safety margin. The treatment is carried out with the use of needle guiding systems for the positioning of the applicators in the lesion, allowing to treat only the cancerous tissue, thus sparing the remaining healthy prostate.

With just one SoracteLite session it is possible to obtain the complete ablation of the lesion with sufficient safety margins, allowing the preservation of healthy tissue and the organ’s function.

SoracteLite for the treatment of Kidney Cancer

The optical fibres are inserted percutaneously to allow the heating of the tissues until they are completely destroyed with a sufficient safety margin. The positioning of the applicators, the monitoring of the treatment, and the verification of the effective coagulation area are carried out under ultrasound guidance. The insertion manoeuvre of the fibres is facilitated by dedicated multi-applicator guiding systems. As these are malignant tumors, the objective of the treatment is a complete ablation of the lesion and the subsequent absence of local post-treatment relapses.

With just one SoracteLite session it is possible to treat kidney tumors of a very wide size and diameter range, thanks to the versatility of the multi-fibre approach. The localised thermal effect of SoracteLite makes it a valuable alternative for patients at high risk of bleeding.

Advantages

transperineal approach for prostate applications
preservation of healthy tissue and organ’s function
highly predictable and repeatable coagulation volume
use of fine, non-traumatic needles
no general anaesthesia
short duration of the treatment (a few minutes)
rapid recovery
no or insignificant post-treatment pain


For more details about the SoracteLite procedure, please visit the dedicated website: www.soractelite.info

 

Clinical Case no.1

Patient suffering from BPH, with a basal volume of 64 ml. Treated with two fibres per lobe.

US image before treatment

Four-month follow-up US image

The four-month follow up revealed the following:

  • volumetric reduction from 64 ml to 37 ml
  • post-urination residue reduction from 200 ml to 43 ml
  • IPSS score reduction from 29 to 10
  • Quality of Life (QoL) from 5 to 1
  • Maximum flow speed up from 4 ml/s to 14 ml/s
  • No complications

Images courtesy of Dr. Patelli (Pesenti Fenaroli Hospital, Alzano Lombardo)

 

 

 

 

Prostate

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study
Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM
Cardiovasc Intervent Radiol (2017).

Kidney

Ultrasound-guided percutaneous laser ablation is safe and effective in the treatment of small renal tumors in patients at increased bleeding risk
Sartori S, Mauri G, Tombesi P, Di Vece F, Bianchi L, Pacella CM
Int J Hyperthermia. 2018 May 11:1-7.

 

 

 

Transperineal Laser Ablation for Treatment of LUTS Due to Benign Prostatic Obstruction

 

Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of Lower Urinary Tract Symptoms in Terms of Long-term Efficacy, Functional Outcomes and Safety

  • No. of Patients:500
  • Sponsor: Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • State of the Study: patients recruitment
  • Registered on ClinicalTrial.gov: ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT03776006

Tolerability of percutaneous ablation Neodymium Laser in patients suffering from Benign Prostatic Hyperplasia (BPH): Prospective Observational Pilot Study

  • No. of patients enrolled: 10
  • Reference centre of the study: Pesenti Fenaroli Hospital, Alzano Lombardo (BG)
  • Promoter: Dr. Gianluigi Patelli
  • Study Status: Completed

 

Applicazioni

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