Temperature Mapping of the Prostate With the Wallterm™ System (WT-DK-TMW08)
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Temperature Mapping of the Prostate With the Wallterm™ System|
- To assess the temperatures within the prostate using the Wallterm System [ Time Frame: Assessed at primary treatment ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||June 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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
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).
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