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Three-dimensional custom-made carbon-fiber prosthesis for sternal reconstruction

Three-dimensional custom-made carbon-fiber prosthesis for sternal reconstruction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013933
Enrollment
Unknown
Registered
2017-12-14
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sternal tumor

Interventions

No:surgery

Sponsors

The Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old male and female; 2. In line with the diagnosis: a huge chest wall tumor, according to the clinical data to consider the expansion of the tumor resection, the need for thoracic reconstruction; 3. According to ECOG score standard Note 1, physical status level 0-2 level; 4. liver and kidney function indicators: serum bilirubin less than twice the upper limit of normal range, alanine aminotransferase (ALT, Glutamic-OxalateTransaminase) or less than three times the upper limit of normal, serum creatinine less than two Times the normal range of the upper limit. The above exception, if considered as a result of tumor invasion, can be excluded; 5. Left ventricular ejection function (LVEF, Left Ventricular Eject Function) up to 45% or greater than 45%; 6. Can accept artificial bone material implantation surgery; 7. Sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. There is a systemic tumor metastasis; 2. tumor invasion of violations of the chest wall outside the site; 3. Tumor infringement of intrathoracic organs, it is difficult to complete excision; 4. Infectious Hepatitis B Virus, Hepatitis C Virus and Human Immunodeficiency Virus; 5. Uncontrolled active infections: systemic fungal, bacterial, viral or other infections; 6. History of Central Nervous System Diseases 7. Patients with uncontrolled mental illness; 8. Incorporate other life-threatening severe organ failure; 9. Major surgery for non-diagnostic purposes within four weeks; 10. Have received other clinical studies within four weeks (observational studies are not included); 11. Pregnant or lactating women; 12. Other things that researchers think are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
lung function;

Countries

China

Contacts

Public ContactFenglei Yu

The Second Xiangya Hospital, Central South University

yufenglei@csu.edu.cn+86 13787128732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026