Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-03 @ 10:30 AM
Study NCT ID:
NCT00662350
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temperature Mapping of the Prostate With the Wallterm™ System
Sponsor:
Pnn Medical A/S
Organization:
Study Overview
Official Title:
Temperature Mapping of the Prostate With the Wallterm™ System
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WT-DK-TMW08
Brief 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: