Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 11:06 AM
Study NCT ID:
NCT05975151
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Sponsor:
Qilu Hospital of Shandong University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Pseudomonas Aeruginosa Followed by Postoperative Intravesical Instillation in Patients With Intermediate and High-risk Non-muscle Invasive Bladder Cancer: a Multi-center, Single-arm Clinical Study
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
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:
This is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive bladder cancer. The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.
Detailed Description:
This study used a multicenter open single-arm study design. Study start: March 2023 Study end: March 2024 Multi-center: Three centers were selected to conduct the study to avoid differences in efficacy due to differences in operation among centers. Single-arm study: A total of 63 subjects with intermediate-high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025.
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?: