NCT00662350

Temperature Mapping of the Prostate With the Wallterm™ System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Pnn Medical A/S · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-04-21
• Last updated: 2010-02-04

Locations

1 site across 1 country: Denmark