Status:
NOT_YET_RECRUITING
Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery
Lead Sponsor:
Tang-Du Hospital
Conditions:
Chest Wall Tumor
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06977022
Start Date
May 1 2025
End Date
May 1 2028
Last Update
May 16 2025
Active Locations (1)
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1
Tangdu Hospitial
Xi'an, Shaanxi, China