An interventional study of Chest wall reconstruction in Chest Wall Tumor, sponsored by Tang-Du Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment
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.
Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who meet all of the following criteria are eligible to participate in the study:
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible for this study:
Participants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants.
Device: Chest wall reconstruction
Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction
Abnormal breathing
Observe the integrity of the chest wall shape and the presence of abnormal breathing
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Implant Degradation Performance Monitoring
Thin-section chest CT + 3D imaging (DICOM format data) * Implant volume changes: Precise measurement of volumetric changes through 3D reconstruction; * Implant density changes: Quantification of density changes using Hounsfield Units (HU values), including adjacent bone tissue changes; ③ Bone resorption/formation: Observation of potential bone loss or new bone formation; ④ Implant structural integrity: Assessment for cracks, voids, or other structural compromises.
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Peri-implant Soft Tissue Evaluation
Chest MRI to evaluate thickening of the pleural fibrous layer surrounding the implant
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Changes in respiratory function--Pulmonary Function Test
The assessment of changes in respiratory function through pulmonary function tests includes indicators such as Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV₁), Total Lung Capacity (TLC), Residual Volume (RV), and Maximum Voluntary Ventilation (MVV).
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Adverse events
Time frame: form date of enrollment until the end of the study, assessed up to 12 months
Plan to share: No
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Tang-Du Hospital