Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270504
Status:
COMPLETED
Last Update Posted:
2009-11-18
First Post:
2005-12-23
Brief Title:
Memokath 044TW Stent for Treatment of Urethral Stricture
Sponsor:
Pnn Medical DK
Organization:
Pnn Medical DK
Study Overview
Official Title:
Prospective Randomized Controlled Multicenter Trial of the Memokath 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra
Status:
COMPLETED
Status Verified Date:
2008-12
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:
None
Brief Summary:
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months following dilation or internal urethrotomy cutting open results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent
Detailed Description:
Patients with bulbar urethral stricture are 21 randomised for either urethral dilation or internal urethrotomy with treatment group or without control group subsequent stenting All patients are followed for up to one year at 4-6 weeks 3 6 9 and 12 months with visual assessment urethroscopy of urethral patency at the treated segment of the urethra The stent is removed at one year In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed
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