Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT05544695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-26
First Post:
2022-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Evidence Study on Cystistat
Sponsor:
MEDA Pharma GmbH & Co. KG
Organization:
Study Overview
Official Title:
Real-world Evidence Observational Study to Evaluate Performance and Safety of Intravesical Sodium Hyaluronate (Cystistat®) in the Treatment of Patients With Interstitial Cystitis (IC) / Bladder Pain Syndrome (BPS)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
IC/BPS
Brief Summary:
This study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime. Cystistat is supplied as a 50 mL solution containing 40 mg of sodium hyaluronate. It is indicated for the temporary replacement of the GAG layer in the bladder.
Detailed Description:
Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.
Study Oversight
Has Oversight DMC:
False
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?: