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Not yet recruiting NCT06977022

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

No phase Interventional Chest Wall Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chest wall reconstruction.
Who it may be relevant to
Registry conditions: Chest Wall Tumor. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery: A Prospective, Single-Arm Phase Il Study

Overview

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.

Interventions

  • Device Chest wall reconstruction
    Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction

Primary outcome measures

  • Abnormal breathing [Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months]
  • Implant Degradation Performance Monitoring [Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months]
  • Peri-implant Soft Tissue Evaluation [Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months]
Secondary outcome measures (2)
  • Changes in respiratory function--Pulmonary Function Test [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tangdu Hospitial — Xi'an

Identifiers

NCT: NCT06977022 · K202504-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗