GelTx™ - Intra-prostatic Gel Injection Treatment for BPH & Prostate Ablation.

Product Description
Product Specifications
How GelTx Works & Clinical Review

 

 

GelTx™ - Product Description

GelTx™ - Intraprostatic Gel Injection treatment for BPH & Enlarged Prostate is a Minimally Invasive Injection treatment for targeted Prostate ablation, under cystoscopic  or ultrasound imaging guidance. The novel, minimally invasive treatment approach involves injecting proprietary Sclerosing Gel formulation directly into the prostate via Trans-Urethral method, under direct Cystoscopic visualization or via Trans-Rectal or Trans-Perineal method, under ‘Real- Time’ Ultrasound imaging guidance. The Image guided Trans- Rectal or Trans-Perineal Gel Injection treatment, using 20 /18 ga echogenic injection needle and commercially available biopsy needle guide can be carried out in physician's office with only local anesthesia. The novel, treatment approach of injecting proprietary Sclerosing Gel formulation directly into the prostate, under imaging guidance is a cost effective alternate to surgical prostatectomy or  prostate surgery (TURP)  for millions of men all over the world.

The GelTx™ - Intra-prostatic Gel Injection Treatment is applicable for all shapes, sizes, & types of Enlarged prostate. The 'Real time' Ultrasound Imaging using Trans-Rectal biplane probe can provide excellent imaging guidance for injection needle placement in the target tissue of  the prostate. The Biplane Ultrasound imaging probe can monitor the precise location of target prostatic tissue, Injection needle and echogenic Sclerosing Gel media and provide 'Real Time' imaging feedback to physician during Gel injection treatment. The Real Time' imaging feedback eliminates the guesswork and provides additional assurance to physician, confirming safety & effectiveness of  the injection treatment, to achieve optimum clinical outcome. The Trans- Urethral Injection method also provide accurate placement of injection needle in to target prostatic tissue, under cystoscopic visualization. The retractable curved injection needle can be advanced into prostatic tissue through urethra, up to 2.0cm with 0.5cm increments. The GelTx – Trans- Urethral Injection device is compatible with all commercially available  Rigid cystoscopes, including Storz, Wolf, Olympus, Circon/ ACMI and others.

The GelTx™ - Intra-prostatic Gel Injection System for Trans-Rectal / Trans- Perineal injection method is available as a sterile, single use Procedure kit containing 20 / 18 ga Echogenic Injection needle device and 3.00 cc Pre- filled Gel Syringes, ( 2ea), packaged in a blister tray package. The GelTx™ - Intra-prostatic  Gel Injection system for Trans-Urethral injection method is available as a sterile, single use Procedure kit containing Trans- urethral injection device to fit appropriate model of the Rigid Cystoscope sheath sizes (19 -21 ga)  and viewing endoscope  (4.0mm) and 3.00 cc Pre- filled Gel Syringes,(2ea) packaged in a blister tray package. The Trans-Urethral injection device is also available to fit commercially available flexible Cystoscope models.
The GelTX™ -Intra-prostatic Gel Injection System does not require purchase of any capital intensive equipment by physicians or hospitals, unlike Laser systems, Radio Frequency Generators, Microwave, Cryo system or Ultrasound equipments. The Intra-prostatic Gel Injection Treatment procedure is cost effective and can be carried out in an ambulatory surgery center without the use of any general anesthesia.

 

GelTx™ - Product Specifications

(A) GelTx™- Trans-Urethral Gel Injection System (Kit):
The GelTx™ - Transurethral Gel injection System for BPH & Enlarged prostate ablation treatment is available as a sterile, single use Procedure kit containing Transurethral Injection needle device to fit appropriate model of the Rigid Cystoscope sheath sizes (19 -21 ga) and viewing endoscope (4.0mm) and 5.00 cc or 10.00cc Pre- filled Gel Syringes ( 2 ea), packaged in a blister tray package.

(B) GelTx™ – Trans-Rectal / Trans- Perineal Gel Injection System (Kit):
The GelTx™- Trans-Rectal / Trans- Perineal Gel injection System for BPH & Enlaraged prostate of is available as a sterile, single use Procedure kit containing 20 / 18 ga echogenic Injection needle (15 /20 cm long ) device and 5.00 cc or 10.00cc Pre- filled Gel Syringes, packaged in a blister tray package.

Universal Compatibility with Imaging Probes:
The GelTx™ -Trans- Rectal / Trans- Perineal Gel injection needles has echogenic tip and are easily visible under conventional ultrasound imaging. The diameter(18ga /20 ga) and length (15 /20cm) of the echogenic needles are designed to be compatible with commercially available Biopsy needle guides and Trans –Rectal Ultrasound imaging probes marketed by Aloka, Siemens, B+K, GE, Toshiba, Sonosite, Medsonics and other ultrasound imaging units.

Dimensions:

(A) Trans-rectal / Trans- perineal Injection Needle:
• Diameter: 18 ga and 20 ga.
• Injection Needle Tip: Echogenic, Chiba Point configuration
• Injection Needle Length: 15 cm and 20cm.
• Needle Tip Profile: Sharp, Bevel Tip with Stylet.
• Optional: Single or Multiple side holes configuration

(B) Trans –Urethral Injection needle Device:
• Diameter : 20 ga
• Retractable Needle length: 2.0 cm max
• Injection Needle Profile: Curved, Sharp, Beveled Point
• Compatibility: Storz, Wolf, Olympus, ACMI / Circon & other Cystoscopes
sheaths & viewing endoscopes.

 

GelTX™- Intraprostatic Gel Injection System for Prostate Ablation Tx

Ordering Information:

Shipped as single use, sterile, 5  Procedure Kits per box.

 

(A) GelTx™- Trans-Urethral Gel Injection System (Kit):

Model #	Product Description
GelTx- TU19S05	GelTx- TU Gel  Injection Kit for Storz 19 Fr Cystoscope & 5 cc (2 ea) Gel syringes
GelTx- TU19O05	GelTx--TU Gel  Injection Kit for Olympus 19 Fr Cystoscope & 5cc (2ea) Gel syringes
GelTx –TU21C05	GelTx- -TU Gel  Injection Kit for Circon19 Fr Cystoscope & 5 cc (2 ea) Gel syringes
GelTx -TU19W05	GelTx- -TU Gel  Injection Kit for Wolf 19 Fr Cystoscope & 5 cc (2 ea) Gel syringes
GelTx- TU19S010	GelTx- TU Gel  Injection Kit for Storz 19 Fr Cystoscope & 10 cc (2 ea) Gel syringes
GelTx- TU19O10	GelTx--TU Gel Injection Kit for Olympus 19 Fr Cystoscope & 10cc (2ea)Gel syringes
GelTx –TU21C10	GelTx- -TU Gel  Injection Kit for Circon19 Fr Cystoscope & 10 cc (2ea) Gel syringes
GelTx -TU19W10	GelTx- -TU Gel  Injection Kit for Wolf 19 Fr Cystoscope & 10 cc (2 ea) Gel syringes

(B) GelTx™ – Trans-Rectal / Trans- Perineal Gel Injection System (Kit):

Model #	Product Description
GelTx-  P18155	GelTx- TR / TP Gel Injection Tx Kit (18 ga /15 cm Needles & 5cc ( 2ea) Gel Syringes
GelTx-  P18205	GelTx- TR / TP Gel  InjectionTx Kit (18 ga /20 cm Needles & 5cc ( 2ea)Gel Syringes
GelTx - P20155	GelTx- TR / TP Gel Injection Tx Kit ( 20 ga /15 cm Needles & 5cc (2 ea) Gel Syringes
GelTx - P20205	GelTx- TR / TP Gel InjectionTx Kit ( 20 ga /20 cm Needles & 5cc ( 2ea)Gel Syringes
GelTx- P181510	GelTx- TR / TP Gel Injection Tx Kit (18 ga / 15cm Needles & 10cc (2ea) Gel Syringes
GelTx-P182010	GelTx- TR / TP Gel  InjectionTx Kit (18 ga / 20 cm Needles & 10cc (2ea) Gel Syringes
GelTx-P201510	GelTx- TR / TP Gel Injection Tx Kit ( 20 ga / 15cm Needles & 10cc (2ea)Gel Syringes
GelTx-P202010	GelTx- TR / TP Gel  Injection Tx Kit ( 20 ga / 20cm Needles & 10cc (2ea) Gel Syringes

Note:

The GelTx™ - Trans- Urethral Injection needles devices can also be ordered separately.

 

GelTx™ - Intra-prostatic Gel Injection Treatment for BPH & Prostate Ablation

How Does GelTx Work?

 

 

(A) Intraprostatic Gel Injection

(B) Effect of Sclerosing Gel on Target cell & Cellular Destruction

 

(C) Ultrasound Imaging Confirmation of Gel placement & Coorelation with Histology & MRI Imaging

(D) Clinical Evaluations & Procedure Outcomes

Research Publication

(1) Controlled Tissue Ablation using ETOH Gel Injection under
Ultrasound / MRI guidance ( Click Here )

(2) Intraprostatic Injection of Gel for the Treatment of Benign
prostatic Hyperplesia: Preliminary Clinical Results ( Click here)

 

Pubmed Publications:

(1) Transurethral ethanol injection therapy of benign prostatic hyperplasia: four-year follow-up.    
Sakr M, Eid A, Shoukry M, Fayed A.

(2) Injectables in the prostate   
Saemi AM, Plante MK.

(3) Effects of direct injection of dehydrated ethanol on PC3 human prostate    cancer cells in nude mice: preliminary study. Goya N, Koga S, Tomizawa Y, Onitsuka S, Yamaguchi Y, Toma H.

(4) Intraprostatic injection of alcohol gel for the treatment of benign prostatic hyperplasia: preliminary clinical results.
Larson BT, Netto N, Huidobro C, de Lima ML, Matheus W, Acevedo C, Larson TR.

(5) Phase I/II examination of transurethral ethanol ablation of the prostate for the treatment of symptomatic benign prostatic hyperplasia.
Plante MK, Marks LS, Anderson R, Amling C, Rukstalis D, Badlani G, Getlin L, Vang

(6) Transurethral ethanol injection for prostatic obstruction: an excellent treatment strategy for persistent urinary retention.
Mutaguchi K, Matsubara A, Kajiwara M, Hanada M, Mizoguchi H, Ohara S, Yasumoto H, Usui T

(7) Intraprostatic injection of 96% ethanol in experimental animal model]
Martov AG, Pavlov DA, Kirpatovskiĭ VI, Kudriavtsev IuV.

(8) Evaluation of the transurethral ethanol ablation of the prostate (TEAP) for symptomatic benign prostatic hyperplasia (BPH): a European multi-center evaluation.
Grise P, Plante M, Palmer J, Martinez-Sagarra J, Hernandez C, Schettini M, Gonzalez-Martin M, Castiñeiras J, Ballanger P, Teillac P, Rolo F, Baena V, Erdmann J, Mirone V.

(9) Transurethral ethanol injection therapy for prostatic hyperplasia: 3-year results.
Goya N, Ishikawa N, Ito F, Kobayashi C, Tomizawa Y, Toma H.

(10) Ethanol injection therapy of the prostate for benign prostatic hyperplasia]
Goya N, Toma H.

 

*Products Available Now for EU Markets, (CE Mark)
Available for Clinical Investigation Only in the U.S. Market
* FDA Clearance pending

   

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