Chest Wall TumorNCT06977022
Clinical Trial on the Efficacy and Safety of Biodegradable 3D-Printed Implants in Chest Wall Reconstruction Surgery
A study testing Chest wall reconstruction in people with Chest Wall Tumor, run by Tang-Du Hospital at 1 site in China.
Trial 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 rib implants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Wall Tumor
- What is being tested?
- Chest wall reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tangdu Hospitial
Xi'an, Shaanxi
Xing Li, +86 02984777551, tangduec@126.com
Xiaolong Yan
About this study
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
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
- Chest Wall Tumor
- Being tested
- Chest wall reconstruction
- Keywords
- PCL Implant, Chest Wall Reconstruction, 3D Printing Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall reconstructionDevice
Extended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Chest wall reconstruction | Experimental | Participants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants. Receives: Device: Chest wall reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal breathing
Observe the integrity of the chest wall shape and the presence of abnormal breathing
Measured: 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.
Measured: 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
Measured: Postoperative 1 month, 3 months, 6 months, and 12 months
Secondary outcomes (2)
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).
Measured: Postoperative 1 month, 3 months, 6 months, and 12 months
Adverse events
Measured: form date of enrollment until the end of the study, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977022
- Sponsor's protocol ID
- K202504-13
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06977022
- Acronym / sponsor ID
- K202504-13
- Conditions
- Chest Wall Tumor
- Keywords
- PCL Implant, Chest Wall Reconstruction, 3D Printing Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest wall reconstruction | Experimental | Device: Chest wall reconstructionParticipants underwent extended resection of chest wall tumors followed by chest wall reconstruction using biodegradable polycaprolactone (PCL) 3D-printed rib implants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who meet all of the following criteria are eligible to participate in the study:
Key exclusion criteria (11 listed)
- Patients who meet any of the following criteria are ineligible for this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest wall reconstructionExtended resection of chest wall tumors with subsequent biodegradable polycaprolactone (PCL) 3D-printed rib prosthetic reconstruction | Device | Chest wall reconstruction |
Primary outcome
Abnormal breathing
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Observe the integrity of the chest wall shape and the presence of abnormal breathing
Implant Degradation Performance Monitoring
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
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.
Peri-implant Soft Tissue Evaluation
Time frame: Postoperative 1 month, 3 months, 6 months, and 12 months
Chest MRI to evaluate thickening of the pleural fibrous layer surrounding the implant
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall reconstruction in people with Chest Wall Tumor, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Yan (+86 15991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal breathing (time frame: Postoperative 1 month, 3 months, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.