Ignite Creation Date:
2024-05-05 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00662350
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2008-04-07
Brief Title:
Temperature Mapping of the Prostate With the Wallterm System
Sponsor:
Pnn Medical AS
Organization:
Pnn Medical AS
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:
None
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?:
None