Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550765
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors A Single-Center Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors
Detailed Description:
The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors The study will be divided into two groups
Experimental Group The tumor lesion area is exposed using conventional methods and the tumor segment is resected according to the principles of tumor-free operation Magnesium metal closure clips are used to clamp the tumor blood vessels osteoperiosteal bleeding points and other bleeding sites The lesion area is thoroughly rinsed to ensure no active bleeding and routine necessary reconstruction is performed
Control Group The tumor lesion area is exposed using conventional methods and the tumor segment is resected according to the principles of tumor-free operation Electrocautery and suture ligation are used to handle the tumor bleeding sites The lesion area is thoroughly rinsed to ensure no active bleeding and routine necessary reconstruction is performed
Experimental Group The tumor lesion area is exposed using conventional methods and the tumor segment is resected according to the principles of tumor-free operation Magnesium metal closure clips are used to clamp the tumor blood vessels osteoperiosteal bleeding points and other bleeding sites The lesion area is thoroughly rinsed to ensure no active bleeding and routine necessary reconstruction is performed
Control Group The tumor lesion area is exposed using conventional methods and the tumor segment is resected according to the principles of tumor-free operation Electrocautery and suture ligation are used to handle the tumor bleeding sites The lesion area is thoroughly rinsed to ensure no active bleeding and routine necessary reconstruction is performed
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