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

NCT06550765 | Not Yet Recruiting DMC

• 1 other identifier: PureMgBoneCuttingEdge
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma, Soft Tissue; Sarcoma, Spindle Cell

Keywords

Soft Tissue sarcoma; biodegradable magnesium metal

Outcome Measures

Primary Outcomes (2)

• 1-year tumor recurrence rate

  Calculate the recurrence rate of the tumor one year after surgery.

  1 year

• Total drainage volume

  Placement of a drainage tube in the surgical area, with postoperative drainage volumes recorded on the first, second, third, and fourth days.

  on the first, second, third, and fourth postoperative days.

Secondary Outcomes (4)

• Blood magnesium ions levels

  at one month and six months after the operation

• Serum alanine aminotransferase (ALT)

  at one month and six months after the operation

• Serum creatinine

  at one month and six months after the operation

• Estimated glomerular filtration rate (eGFR）

  at one month and six months after the operation

Study Arms (2)

Control group

NO INTERVENTION

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.

Magnesium metal closure clips

EXPERIMENTAL

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.

Device: Biodegradable Magnesium Metal Clips

Interventions

Biodegradable Magnesium Metal Clips 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.

Magnesium metal closure clips

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, 516008, China

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yu Zhang, Ph.D.

CONTACT

8613602744495; luck_2001@126.com

Yonghan Chen, Bachelor

CONTACT

8615602384042; chen_yh2000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 13, 2024
• Study Start: August 25, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)