Temperature Mapping of the Prostate With the Wallterm™ System (WT-DK-TMW08)

This study has been completed.
Sponsor:
Information provided by:
Pnn Medical A/S
ClinicalTrials.gov Identifier:
NCT00662350
First received: April 7, 2008
Last updated: February 3, 2010
Last verified: February 2010

April 7, 2008
February 3, 2010
June 2008
July 2009   (final data collection date for primary outcome measure)
To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00662350 on ClinicalTrials.gov Archive Site
  • To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
  • Delineate the extent and the location of necrosis [ Time Frame: Short term ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Temperature Mapping of the Prostate With the Wallterm™ System
Temperature Mapping of the Prostate With the Wallterm™ System

To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH).

The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Men with BPH

Benign Prostatic Hyperplasia
Device: The Wallterm™ System
The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).
Other Names:
  • Wallterm™ Catheter (model 3010)
  • Wallterm™ Central Unit (model 3020-10)
Symptomatic Benign Protate Hypertrophy
Symptom Score (IPSS) greater than 15, requiring invasive treatment, Prostate size greater than 25 g, Prostatic urethra length between 2.0 cm and 5.5 cm
Intervention: Device: The Wallterm™ System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
August 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men with symptomatic BPH requiring treatment,
  • IPSS score > 15
  • Age > 50 years
  • Prostate size of 25 g or greater
  • Prostatic urethra length between 2.0 cm and 5.5 cm,
  • Ability to understand and consent to participate in this investigation,
  • Willingness and ability to participate in all required follow-up evaluations.

Exclusion Criteria:

  • Allergy towards Silicone,
  • Peak Urinary Flow > 15 mL/s,
  • Penile or urinary sphincter implant,
  • Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)
  • Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,
  • Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound,
  • Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).
  • Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.
  • Patients with confirmed or suspected bladder cancer.
  • Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.
  • Patients with gross haematuria. (Note: These patients may be eligible for this investigation if the results of a careful workup for cancer, including an X-ray study, cystoscopy and cytology, are found to be negative.)
  • Patients with a history of bladder neck contracture.
  • Patients who presently have urethral strictures, which prevent the passage of a 20 Fr endoscope (these patients may be treated after successful treatment of the stricture).
  • Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).
  • Patients interested in future fertility.
  • Patients who have chronic catheter drainage due to urinary retention (these patients may be treated if a CMG demonstrates that the patient has a contractile bladder).
  • Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.
  • Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.
  • Patients with compromised renal function (i.e. serum creatinine >150 mls/l), renal or upper tract dilatation.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00662350
WT-DK-TMW08
No
Jacob Hyllested-Winge, M.D., VP, Director Clinical And Regulatory, Pnn Medical
Pnn Medical A/S
Not Provided
Principal Investigator: Jørgen Nordling, Professor Urological Dep., Herlev Hospital, Denmark
Pnn Medical A/S
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP