Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia
NCT ID: NCT04198103
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2018-11-01
2020-03-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SoracteLite
Transperineal Focal Laser Ablation (TPLA)
Transperineal Focal Laser Ablation (TPLA)
The intervention will take place in an ambulatory setting using EchoLaser system. The treatment consists of the trasmission of laser energy into the tissue through the percutaneous insertion of optical fiber under local anesthesia. Within each needle, an optic fiber of 300 µm will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 3W. At the end of the first ablation there is a pull-back of about 1 cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used for a total duration of about 30minutes. At the end of the treatment corticosteroid is given for anti-edema and anti-inflammatory effects and Antibiotic therapy and gastroprotective therapy is given. After an adequate amount of time for observation, the patient is dismissed.
Interventions
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Transperineal Focal Laser Ablation (TPLA)
The intervention will take place in an ambulatory setting using EchoLaser system. The treatment consists of the trasmission of laser energy into the tissue through the percutaneous insertion of optical fiber under local anesthesia. Within each needle, an optic fiber of 300 µm will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 3W. At the end of the first ablation there is a pull-back of about 1 cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used for a total duration of about 30minutes. At the end of the treatment corticosteroid is given for anti-edema and anti-inflammatory effects and Antibiotic therapy and gastroprotective therapy is given. After an adequate amount of time for observation, the patient is dismissed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 50 years of age
* International Prostate Symptoms (IPSS) ≥12
* Peak urinary flow rate (Qmax): \<15 ml
* Prostate volume: ≥ 30 ml, measured by transrectal ultrasound
* Post-void residual (PVR): \<400 ml
* Signed informed consent
Exclusion Criteria
* urethral stenosis
* serious coagulation disorders
* inadequate compliance
* ischemic pathology in the previous six months
* active phase inflammatory pathology
50 Years
MALE
No
Sponsors
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Ospedale Regina Apostolorum
OTHER
European Institute of Oncology
OTHER
University of Rome Tor Vergata
OTHER
Responsible Party
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Guglielmo Manenti
Principle Investigator
Locations
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Casa di Cura Santa Rita
Atripalda, AV, Italy
ASST Bergamo Est
Seriate, BG, Italy
Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
Rome, RM, Italy
IGreco Ospedali Riuniti
Cosenza, , Italy
Countries
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References
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Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.
Raz O, Haider MA, Davidson SR, Lindner U, Hlasny E, Weersink R, Gertner MR, Kucharczyk W, McCluskey SA, Trachtenberg J. Real-time magnetic resonance imaging-guided focal laser therapy in patients with low-risk prostate cancer. Eur Urol. 2010 Jul;58(1):173-7. doi: 10.1016/j.eururo.2010.03.006. Epub 2010 Mar 12.
Lindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14.
Goldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais D, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG; Society of Interventional Radiology Technology Assessment Committee. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2005 Jun;16(6):765-78. doi: 10.1097/01.RVI.0000170858.46668.65.
Bremer C, Kreft G, Roggan A, Filler T, Reimer P. Ex vivo evaluation of novel miniaturized laser-induced interstitial thermotherapy applicators for effective small-volume tissue ablation. Invest Radiol. 2001 Jun;36(6):327-34. doi: 10.1097/00004424-200106000-00005.
Costello AJ, Bowsher WG, Bolton DM, Braslis KG, Burt J. Laser ablation of the prostate in patients with benign prostatic hypertrophy. Br J Urol. 1992 Jun;69(6):603-8. doi: 10.1111/j.1464-410x.1992.tb15631.x.
Other Identifiers
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RS.99
Identifier Type: -
Identifier Source: org_study_id