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Trial Title:
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
NCT ID:
NCT06550765
Condition:
Sarcoma, Soft Tissue
Sarcoma, Spindle Cell
Conditions: Official terms:
Sarcoma
Soft Tissue Neoplasms
Conditions: Keywords:
Soft Tissue sarcoma
biodegradable magnesium metal
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Biodegradable Magnesium Metal Clips
Description:
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.
Arm group label:
Magnesium metal closure clips
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants must be of either gender, aged between 18 and 65 years;
2. Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma,
liposarcoma, or other bone and soft tissue sarcomas;
3. Must have undergone standard chemotherapy and require en bloc resection;
4. 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 Criteria:
1. Severe dysfunction of the heart, liver, kidney, lung, or brain.
2. Pregnant women or women who are breastfeeding.
3. History of autoimmune disease, HIV infection, history of immunosuppressive disorder,
or currently taking immunosuppressive drugs.
4. History of syphilis (Treponema pallidum), active infection with hepatitis B or C,
and positive for verified antigens.
5. Participation in any other clinical study currently or within 3 months prior to the
screening visit.
6. Patients have any other conditions that the researcher deems unsuitable for the
study. Age is between 18 to 75 years old.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong provincial people's hospital
Address:
City:
Guangzhou
Zip:
516008
Country:
China
Start date:
August 25, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06550765
