Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT06779461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-16
First Post:
2024-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Sponsor:
InnoBM Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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 goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.
The main questions it aims to answer are:
* Is the treatment more effective than traditional TACE alone?
* What additional medical issues arise when using the microspheres?
Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.
Participants will:
* Receive up to 3 treatments of TACE with or without microspheres
* Undergo checkups and tests every 30 days
* Keep records of tumor size and other safety issues
The main questions it aims to answer are:
* Is the treatment more effective than traditional TACE alone?
* What additional medical issues arise when using the microspheres?
Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.
Participants will:
* Receive up to 3 treatments of TACE with or without microspheres
* Undergo checkups and tests every 30 days
* Keep records of tumor size and other safety issues
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: