Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812482
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-03-15
Brief Title:
Treatment of Urethral Stricture With Urethral Drug Ball
Sponsor:
Lepu Medical Technology Beijing Co Ltd
Organization:
Lepu Medical Technology Beijing Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Urethral Drug Balloon Catheter in the Treatment of Urethral Stricture
Status:
RECRUITING
Status Verified Date:
2022-08
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:
To evaluate the safety and efficacy of urethral drug balloon catheter in the treatment of urethral stricture
Detailed Description:
This is a prospective multicenter randomized controlled and superiority study The two groups were randomly selected into a total of 150 subjects 75 in the test group and 75 in the control group according to 11 The test group was treated with urethral drug balloon catheter from Lepu Medical Technology Beijing CoLtd while the control group was treated with direct vision internal urethrotomy DVIU
All subjects were followed up at 1 3 and 6 months post-procedure and the efficacy of urethral drug balloon catheter will be evaluated with the success rate of operation at 6 months as the main end point Observe the occurrence of complications and other indicators to make a reliable evaluation of the safety of urethral drug balloon catheter
All subjects were followed up at 1 3 and 6 months post-procedure and the efficacy of urethral drug balloon catheter will be evaluated with the success rate of operation at 6 months as the main end point Observe the occurrence of complications and other indicators to make a reliable evaluation of the safety of urethral drug balloon catheter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None