Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery

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Updated on 24 June 2026
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Summary

This project focuses on patients with chest wall tumors who are expected to have a maximum intraoperative anterolateral chest wall defect diameter of 5-10 cm and require chest wall reconstruction with rib implants. It aims to evaluate the efficacy and safety of biodegradable 3D-printed implants in chest wall reconstruction surgery, providing a superior reconstruction strategy for patients with tumor-induced chest wall defects.

Details
Condition Chest Wall Tumor
Clinical Study IdentifierTX16613
Last Modified on24 June 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients who meet all of the following criteria are eligible to participate in the study
Aged 18-70 years
No gender restriction
ECOG Performance Status 0-1
Chest CT-confirmed chest wall-originating tumor
Histologically/cytologically confirmed primary or metastatic chest wall tumor
Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed)
Scheduled for prosthetic chest wall reconstruction
No prior chest wall reconstruction surgery
Willing to provide written informed consent and comply with follow-up visits and protocol requirements

Exclusion Criteria

Patients who meet any of the following criteria are ineligible for this study
Patients with posterior chest wall defects
Uncontrolled underlying medical conditions or contraindications to general anesthesia
Pregnant or lactating women
Concurrent severe comorbidities that may interfere with study evaluations, including: Severe hepatic, cardiac, or renal diseases; Active malignancies (other than the indicated chest wall tumor); Alcohol use disorder
lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements
Women of childbearing potential and their partners unwilling to use effective contraception
Prior history of chest wall reconstruction surgery
Active uncontrolled bacterial, fungal, or viral infections
Participation in other clinical trials within 3 months prior to enrollment
Any other conditions deemedunsuitable by the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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