Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors

NCT ID: NCT06550765

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-25
• Study Completion Date: 2027-12-31

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.

Conditions

Sarcoma, Soft Tissue; Sarcoma, Spindle Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

The tumor lesion area is exposed using conventional surgery 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Magnesium metal closure clips

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.

Group Type: EXPERIMENTAL

Biodegradable Magnesium Metal Clips

Intervention Type: DEVICE

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.

Interventions

Biodegradable Magnesium Metal Clips

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Yu Zhang, Ph.D.

Role: CONTACT

luck_2001@126.com

8613602744495

Yonghan Chen, Bachelor

Role: CONTACT

chen_yh2000@163.com

8615602384042

Other Identifiers

PureMgBoneCuttingEdge

Identifier Type: -

Identifier Source: org_study_id