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

Launched by TANG-DU HOSPITAL · May 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment for patients with chest wall tumors, specifically those who need surgery to rebuild the chest wall. The researchers want to see if using special biodegradable 3D-printed implants can help make the surgery safer and more effective. These implants are designed to break down naturally in the body after they have done their job, which could offer a better option for patients who have a defect in their chest wall due to a tumor. The trial is still in the planning stages and has not started recruiting participants yet.

To be eligible for this study, patients must be between 18 and 70 years old and have a confirmed chest wall tumor that requires surgery. They should be scheduled for chest wall reconstruction and should not have had any previous surgeries in that area. Participants will need to be willing to provide consent and attend follow-up visits to monitor their progress. It’s important to note that certain health conditions or prior treatments may disqualify someone from participating, so anyone interested should discuss their individual situation with their doctor. Overall, this trial aims to find a safer and more effective way to help patients recover from chest wall tumors.

Gender

ALL

Eligibility criteria

• 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