Clinical trial · Interventional
Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery
Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery: A Prospective, Single-Arm Phase Il Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chest Wall Tumor | Chest Wall Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest wall reconstruction | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chest wall reconstruction
- description
- Participants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants.
- interventionNames
- Device: Chest wall reconstruction
Primary outcomes (3)
- measure
- Abnormal breathing
- timeFrame
- Postoperative 1 month, 3 months, 6 months, and 12 months
- description
- Observe the integrity of the chest wall shape and the presence of abnormal breathing
- measure
- Implant Degradation Performance Monitoring
- timeFrame
- Postoperative 1 month, 3 months, 6 months, and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who meet all of the following criteria are eligible to participate in the study: 1. Aged 18-70 years; 2. No gender restriction; 3. ECOG Performance Status 0-1; 4. Chest CT-confirmed chest wall-originating tumor; 5. Histologically/cytologically confirmed primary or metastatic chest wall tumor; 6. Anticipated intraoperative anterolateral chest wall defect diameter 5-10 cm (maximum) or costal arch reconstruction required (investigator-assessed); 7. Scheduled for prosthetic chest wall reconstruction; 8. No prior chest wall reconstruction surgery; 9. 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: 1. Patients with posterior chest wall defects; 2. Uncontrolled underlying medical conditions or contraindications to general anesthesia; 3. Pregnant or lactating women; 4. 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 5. lnability to provide reliable symptom reporting due to:P sychiatric disorders, Severe neurosis, Non-compliance with trial requirements 6. Women of childbearing potential\* and their partners unwilling to use effective contraception; 7. Prior history of chest wall reconstruction surgery; 8. Active uncontrolled bacterial, fungal, or viral infections; 9. Participation in other clinical trials within 3 months prior to enrollment; 10. Any other conditions deemedunsuitable by the investigator
References
Publications (0)
Data not yet available