Status:
NOT_YET_RECRUITING
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Sarcoma, Soft Tissue
Sarcoma, Spindle Cell
Eligibility:
All Genders
18-65 years
Phase:
NA
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 tu...
Eligibility Criteria
Inclusion
- Participants must be of either gender, aged between 18 and 65 years;
- Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
- Must have undergone standard chemotherapy and require en bloc resection;
- Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.
Exclusion
- Severe dysfunction of the heart, liver, kidney, lung, or brain.
- Pregnant women or women who are breastfeeding.
- History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.
- History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.
- Participation in any other clinical study currently or within 3 months prior to the screening visit.
- Patients have any other conditions that the researcher deems unsuitable for the study. Age is between 18 to 75 years old.
Key Trial Info
Start Date :
August 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06550765
Start Date
August 25 2024
End Date
December 31 2027
Last Update
August 13 2024
Active Locations (1)
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1
Guangdong provincial people's hospital
Guangzhou, Guangdong, China, 516008