Chest Wall TumorsPRODIPETNCT07018960
"Multicenter Registry for Chest Wall Reconstruction Using Custom Dynamic Prostheses (PRODIPET)"
A study testing Chest wall reconstruction with 3D printed titan custom prothesis in people with Chest Wall Tumors and Post-traumatic Syndrome, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
Trial summary
PRODIPET Study Summary Title: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses Purpose The PRODIPET study evaluates the safety and effectiveness of personalized, dynamic titanium prostheses for reconstructing the chest wall after: Tumor resection (e.g., sarcomas, lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Wall Tumors, Post-traumatic Syndrome, Malignant Bone Tumor of Chest Wall
- What is being tested?
- Chest wall reconstruction with 3D printed titan custom prothesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Mar 2024to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet ALL of the following:
- Age: ≥18 years
- Clinical Indication:
- Requires chest wall reconstruction due to:
- Oncologic resection (primary tumors, metastases)
- Traumatic injury (flail chest, severe rib fractures)
Show all 16Show fewer
- Post-infection/post-radiation defects
- Defect Characteristics:
- Involves ≥2 ribs or sternum with instability
- Minimum defect size: 5 cm in largest dimension
- Surgical Plan:
- Scheduled for reconstruction with 3D-printed custom titanium prosthesis
- Consent: Willing to provide informed consent for:
- Surgery
- Data collection
- Follow-up evaluations
Who cannot join
- Patients will be excluded if ANY of the following apply:
- Medical Contraindications:
- Active systemic infection (e.g., sepsis)
- Severe cardiopulmonary disease (FEV₁ <30% predicted)
- Uncorrectable coagulopathy (INR >1.5)
- Technical Limitations:
Show all 16Show fewer
- Inadequate soft tissue coverage for prosthesis
- Vertebral column involvement requiring complex fixation
- Material Incompatibility:
- Known hypersensitivity to titanium alloys
- Study Logistics:
- Participation in another conflicting clinical trial
- Inability to complete follow-up (e.g., no fixed address)
- Ethical Considerations:
- Pregnancy (due to elective CT scan requirements)
- Prisoners or cognitively impaired patients without legal guardians
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario de La Ribera
Alzira, Valencia
Jose Galbis Carvajal., Medicine, 0034962542800, clinicagalbiscirugiatoracica@gmail.com
- Recruiting
Hospital Universitario Josep Trueta
Barcelona, Catalonia
Juan Carlos Trujillo-Reyes, Medicine, 0034 972940200, jtrujillo@santpau.cat
- Recruiting
Hospital de Cruces
Cruces, Basque Country
Unai Jiménez Maestre, Medicine, 0034 946006000, u.jimenezmaestre@gmail.com
- Recruiting
Complejo Hospitalario Universitario Insular
Las Palmas de Gran Canaria, Canary Islands
José Ramón Cano García, Medicine, 0034 928444000, joseravich@gmail.com
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid
Nicolás Moreno Mata
About this study
Official title: "Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET"
PRODIPET Study Summary
Title: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses
Read more
Purpose
The PRODIPET study evaluates the safety and effectiveness of personalized, dynamic titanium prostheses for reconstructing the chest wall after:
Tumor resection (e.g., sarcomas, lung cancer). Severe trauma (e.g., multiple rib fractures). Traditional methods (metal plates, mesh) often lack flexibility, potentially causing pain or breathing difficulties. This study tests 3D-printed titanium implants designed to mimic natural rib movement, improving function and comfort.
Study Design
Type: Multicenter, ambispective (retrospective + prospective data).
Duration:
Prospective: 24 months (Jan 2024-Jan 2026). Follow-up: 12 months per patient (final analysis by 2027). Centers: Major Spanish hospitals (Ramón y Cajal/Madrid, La Ribera/Alzira, Cruces/Baracaldo, Insular/Las Palmas).
Key Goals
Assess short/mid-term outcomes (pain, breathing, complications). Compare results across patients/surgical techniques. Improve future prosthesis designs. Who Can Participate?
Inclusion:
Adults (18+) needing chest wall reconstruction. Signed consent for anonymized data sharing.
Exclusion:
Titanium allergies. Participation in conflicting studies. Patient Experience
Pre-Surgery:
CT scan creates a custom 3D prosthesis (made by Osteobionix® using Ti6AL4V-ELI titanium).
Surgery:
Surgeons implant the prosthesis, anchoring it to ribs/sternum.
Follow-Up:
Evaluations at discharge, 1/6/12 months (in-person or phone). Measures: Pain, lung function, imaging (X-ray/CT), complications (e.g., infection, implant failure).
Privacy \& Ethics
Data is anonymized and stored securely (REDCap system). Complies with European General Data Protection Regulation (EU GDPR) and Spanish data protection laws.
Patients may withdraw anytime. For Healthcare Providers
Collaboration: Open to thoracic surgeons/researchers. Data Access: Centralized via REDCap; analyzed by the coordinating team. Publications: Multicenter results will be published first; individual centers may later share their data.
Why This Matters
Addresses a gap in evidence for dynamic prostheses, which may offer:
Better breathing mechanics vs. rigid materials. Fewer long-term complications (e.g., breakage). Could standardize best practices for complex reconstructions. Contact
Lead Coordinator: Dr. Nicolás Moreno Mata (Hospital Ramón y Cajal, Madrid). Email: nicolas.moreno.hrc@gmail.com | Phone: +34 647 609 363.
Key Takeaways:
Patients/Families: Learn if custom prostheses improve recovery. Providers: Contribute to advancing surgical options. Researchers: Access multicenter data on innovative implants.
Read the detailed description
Here's a detailed yet accessible description of the PRODIPET study:
PRODIPET Study: A Comprehensive Multicenter Investigation into 3D-Printed Titanium Chest Wall Reconstruction
Background and Rationale Chest wall defects resulting from tumor resections or traumatic injuries present significant surgical challenges. Traditional reconstruction methods using rigid materials like methylmethacrylate or steel plates often compromise respiratory mechanics and patient comfort. The PRODIPET study examines an innovative solution: patient-specific, 3D-printed titanium prostheses designed to replicate natural chest wall dynamics.
Study Design and Methodology
This national multicenter registry combines:
- Retrospective data: Cases from participating centers where titanium prostheses were previously implanted
- Prospective data: New cases enrolled over a 24-month period (January 2024-January 2026)
Technical Innovation
The prostheses are:
- Custom-designed using preoperative CT scans
- Manufactured via electron beam melting of Ti6AL4V-ELI titanium powder
- Engineered to provide:
- Anatomical precision
- Dynamic flexibility mimicking natural rib movement
- Reduced imaging artifacts for better postoperative monitoring
Clinical Protocol
- Preoperative Phase:
- Multidisciplinary evaluation (surgeons, radiologists, engineers)
- Virtual surgical planning using 3D reconstruction
- Prosthesis fabrication by Osteobionix® (2-3 week turnaround)
- Surgical Phase:
- Resection of affected chest wall segment
- Implantation of custom prosthesis
- Fixation to remaining ribs/sternum
- Postoperative Follow-up:
- Standardized evaluations at:
- Hospital discharge
- 1 month
- 6 months
- 12 months
- Assessments include:
- Pulmonary function tests
- Pain scales (VAS)
- CT imaging
- Quality of life questionnaires
Data Collection and Management
- Secure REDCap database hosted by EJIE (Informatic Society of Basque Government, IT)
- Comprehensive variables tracked:
- Demographic data
- Surgical details (operative time, blood loss)
- Prosthesis characteristics (size, fixation method)
- Complication rates
- Functional outcomes
Participant Protection
- CEIm (ethical committee)-approved protocol (Hospital Ramón y Cajal Ethics Committee)
- GDPR-compliant data handling
- Two-tier identification system:
- Local centers maintain identifiable information
- Central registry uses anonymized codes
- Right to withdraw without penalty
Scientific Objectives
Primary:
- Determine prosthesis durability (12-month failure rate)
- Assess restoration of pulmonary function
Secondary:
- Identify optimal candidates for this technique
- Establish complication profiles
- Compare outcomes across surgical centers
- Refine prosthesis design parameters
Clinical Significance
This study addresses critical gaps in thoracic reconstruction by:
- Providing real-world evidence for a novel technology
- Establishing standardized protocols
- Creating a benchmark for future innovations
- Potentially improving quality of life for patients requiring extensive chest wall resection
Collaborative Structure
- Coordinating Committee: 4 lead thoracic surgeons
- Participating Centers: Open to all Spanish hospitals meeting criteria
- Industry Partner: Osteobionix® (device fabrication only, no data access)
Dissemination Plan
- Interim analysis at 12 months
- Final results publication anticipated 2027
- Data sharing policy:
- Coordinating committee controls primary dataset
- Participating centers may publish local data after multicenter publication
This rigorous, patient-focused investigation represents a significant advancement in thoracic surgical care, combining cutting-edge engineering with clinical expertise to improve outcomes for patients with complex chest wall defects.
- Being tested
- Chest wall reconstruction with 3D printed titan custom prothesis
- Keywords
- Chest wall tumors, Chest wall reconstruction, Custom 3D-Printed Titanium Prostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall reconstruction with 3D printed titan custom prothesisProcedure or surgery
Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses"
- Intervention Overview
A custom-designed, 3D-printed titanium prosthesis is surgically implanted to reconstruct chest wall defects following oncologic resection or traumatic injury. The prosthesis is engineered to:
Restore structural integrity of the thoracic cavity Preserve physiological chest wall dynamics during respiration Provide long-term biomechanical stability
| Study group | Role | What they receive |
|---|---|---|
| "Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses" | Experimental | Not described Receives: Procedure: Chest wall reconstruction with 3D printed titan custom prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction
*Measured via spirometry according to ATS/ERS /The American Thoracic Society/European respiratory society) standards at 30 days and 1 year postoperatively*
Measured: From enrollment to the end of treatment at 1 year
Change from Preoperative Baseline in Forced Vital Capacity (FVC)
*Measured via spirometry according to ATS/ERS standards at 30 days and 1 year postoperatively*
Measured: From enrollment to the end of treatment at 1 year
Change from Preoperative Baseline in FEV₁/FVC Ratio
Calculated from spirometry results at 30 days and 1 year postoperatively
Measured: From enrollment to the end of treatment at 1 year
Change from Preoperative Baseline in Peak Expiratory Flow (PEF)
Measured via spirometry at 30 days and 1 year postoperatively
Measured: From enrollment to the end of treatment at 1 year
Change from Preoperative Baseline in Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%)
Measured via spirometry at 30 days and 1 year postoperatively
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de la Ribera, Hospital de Cruces, Hospital Universitario Insular Gran Canaria, University Hospital of Girona Dr. Josep Trueta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018960
- Sponsor's protocol ID
- PRODIPET
- Acronym
- PRODIPET
- Status last verified
- Aug 2025
- First submitted
- 26 May 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Multicenter Registry for Chest Wall Reconstruction Surgery Using Custom Dynamic Prostheses PRODIPET"
- ClinicalTrials.gov ID
- NCT07018960
- Acronym / sponsor ID
- PRODIPET / PRODIPET
- Keywords
- Chest wall tumors, Chest wall reconstruction, Custom 3D-Printed Titanium Prostheses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Hospital Universitario de la Ribera, Hospital de Cruces, Hospital Universitario Insular Gran Canaria, University Hospital of Girona Dr. Josep Trueta
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jun 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.
PRODIPET Study Summary
Title: Multicenter Registry for Chest Wall Reconstruction Using Custom 3D-Printed Titanium Prostheses
Purpose
The PRODIPET study evaluates the safety and effectiveness of personalized, dynamic titanium prostheses for reconstructing the chest wall after:
Tumor resection (e.g., sarcomas, lung cancer). Severe trauma (e.g., multiple rib fractures). Traditional methods (metal plates, mesh) often lack flexibility, potentially causing pain or breathing difficulties. This study tests 3D-printed titanium implants designed to mimic natural rib movement, improving function and comfort.
Study Design
Type: Multicenter, ambispective (retrospective + prospective data).
Duration:
Prospective: 24 months (Jan 2024-Jan 2026). Follow-up: 12 months per patient (final analysis by 2027). Centers: Major Spanish hospitals (Ramón y Cajal/Madrid, La Ribera/Alzira, Cruces/Baracaldo, Insular/Las Palmas).
Key Goals
Assess short/mid-term outcomes (pain, breathing, complications). Compare results across patients/surgical techniques. Improve future prosthesis designs. Who Can Participate?
Inclusion:
Adults (18+) needing chest wall reconstruction. Signed consent for anonymized data sharing.
Exclusion:
Titanium allergies. Participation in conflicting studies. Patient Experience
Pre-Surgery:
CT scan creates a custom 3D prosthesis (made by Osteobionix® using Ti6AL4V-ELI titanium).
Surgery:
Surgeons implant the prosthesis, anchoring it to ribs/sternum.
Follow-Up:
Evaluations at discharge, 1/6/12 months (in-person or phone). Measures: Pain, lung function, imaging (X-ray/CT), complications (e.g., infection, implant failure).
Privacy \& Ethics
Data is anonymized and stored securely (REDCap system). Complies with European General Data Protection Regulation (EU GDPR) and Spanish data protection laws.
Patients may withdraw anytime. For Healthcare Providers
Collaboration: Open to thoracic surgeons/researchers. Data Access: Centralized via REDCap; analyzed by the coordinating team. Publications: Multicenter results will be published first; individual centers may later share their data.
Why This Matters
Addresses a gap in evidence for dynamic prostheses, which may offer:
Better breathing mechanics vs. rigid materials. Fewer long-term complications (e.g., breakage). Could standardize best practices for complex reconstructions. Contact
Lead Coordinator: Dr. Nicolás Moreno Mata (Hospital Ramón y Cajal, Madrid). Email: nicolas.moreno.hrc@gmail.com | Phone: +34 647 609 363.
Key Takeaways:
Patients/Families: Learn if custom prostheses improve recovery. Providers: Contribute to advancing surgical options. Researchers: Access multicenter data on innovative implants.
Detailed description
Here's a detailed yet accessible description of the PRODIPET study:
PRODIPET Study: A Comprehensive Multicenter Investigation into 3D-Printed Titanium Chest Wall Reconstruction
Background and Rationale Chest wall defects resulting from tumor resections or traumatic injuries present significant surgical challenges. Traditional reconstruction methods using rigid materials like methylmethacrylate or steel plates often compromise respiratory mechanics and patient comfort. The PRODIPET study examines an innovative solution: patient-specific, 3D-printed titanium prostheses designed to replicate natural chest wall dynamics.
Study Design and Methodology
This national multicenter registry combines:
- Retrospective data: Cases from participating centers where titanium prostheses were previously implanted
- Prospective data: New cases enrolled over a 24-month period (January 2024-January 2026)
Technical Innovation
The prostheses are:
- Custom-designed using preoperative CT scans
- Manufactured via electron beam melting of Ti6AL4V-ELI titanium powder
- Engineered to provide:
- Anatomical precision
- Dynamic flexibility mimicking natural rib movement
- Reduced imaging artifacts for better postoperative monitoring
Clinical Protocol
- Preoperative Phase:
- Multidisciplinary evaluation (surgeons, radiologists, engineers)
- Virtual surgical planning using 3D reconstruction
- Prosthesis fabrication by Osteobionix® (2-3 week turnaround)
- Surgical Phase:
- Resection of affected chest wall segment
- Implantation of custom prosthesis
- Fixation to remaining ribs/sternum
- Postoperative Follow-up:
- Standardized evaluations at:
- Hospital discharge
- 1 month
- 6 months
- 12 months
- Assessments include:
- Pulmonary function tests
- Pain scales (VAS)
- CT imaging
- Quality of life questionnaires
Data Collection and Management
- Secure REDCap database hosted by EJIE (Informatic Society of Basque Government, IT)
- Comprehensive variables tracked:
- Demographic data
- Surgical details (operative time, blood loss)
- Prosthesis characteristics (size, fixation method)
- Complication rates
- Functional outcomes
Participant Protection
- CEIm (ethical committee)-approved protocol (Hospital Ramón y Cajal Ethics Committee)
- GDPR-compliant data handling
- Two-tier identification system:
- Local centers maintain identifiable information
- Central registry uses anonymized codes
- Right to withdraw without penalty
Scientific Objectives
Primary:
- Determine prosthesis durability (12-month failure rate)
- Assess restoration of pulmonary function
Secondary:
- Identify optimal candidates for this technique
- Establish complication profiles
- Compare outcomes across surgical centers
- Refine prosthesis design parameters
Clinical Significance
This study addresses critical gaps in thoracic reconstruction by:
- Providing real-world evidence for a novel technology
- Establishing standardized protocols
- Creating a benchmark for future innovations
- Potentially improving quality of life for patients requiring extensive chest wall resection
Collaborative Structure
- Coordinating Committee: 4 lead thoracic surgeons
- Participating Centers: Open to all Spanish hospitals meeting criteria
- Industry Partner: Osteobionix® (device fabrication only, no data access)
Dissemination Plan
- Interim analysis at 12 months
- Final results publication anticipated 2027
- Data sharing policy:
- Coordinating committee controls primary dataset
- Participating centers may publish local data after multicenter publication
This rigorous, patient-focused investigation represents a significant advancement in thoracic surgical care, combining cutting-edge engineering with clinical expertise to improve outcomes for patients with complex 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 |
|---|---|---|
| "Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses" | Experimental | Procedure: Chest wall reconstruction with 3D printed titan custom prothesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: ≥18 years
- Requires chest wall reconstruction due to:
- Oncologic resection (primary tumors, metastases)
- Traumatic injury (flail chest, severe rib fractures)
- Post-infection/post-radiation defects
Key exclusion criteria (16 listed)
- Medical Contraindications:
- Active systemic infection (e.g., sepsis)
- Severe cardiopulmonary disease (FEV₁ <30% predicted)
- Uncorrectable coagulopathy (INR >1.5)
- Technical Limitations:
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 reconstruction with 3D printed titan custom prothesisDynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses" 1. Intervention Overview A custom-designed, 3D-printed titanium prosthesis is surgically implanted to reconstruct chest wall defects following oncologic resection or traumatic injury. The prosthesis is engineered to: Restore structural integrity of the thoracic cavity Preserve physiological chest wall dynamics during respiration Provide long-term biomechanical stability | Procedure or surgery | "Dynamic Chest Wall Reconstruction with Patient-Specific 3D-Printed Titanium Prostheses" |
Primary outcome
Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction
Time frame: From enrollment to the end of treatment at 1 year
*Measured via spirometry according to ATS/ERS /The American Thoracic Society/European respiratory society) standards at 30 days and 1 year postoperatively*
Change from Preoperative Baseline in Forced Vital Capacity (FVC)
Time frame: From enrollment to the end of treatment at 1 year
*Measured via spirometry according to ATS/ERS standards at 30 days and 1 year postoperatively*
Change from Preoperative Baseline in FEV₁/FVC Ratio
Time frame: From enrollment to the end of treatment at 1 year
Calculated from spirometry results at 30 days and 1 year postoperatively
Change from Preoperative Baseline in Peak Expiratory Flow (PEF)
Time frame: From enrollment to the end of treatment at 1 year
Measured via spirometry at 30 days and 1 year postoperatively
Change from Preoperative Baseline in Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%)
Time frame: From enrollment to the end of treatment at 1 year
Measured via spirometry at 30 days and 1 year postoperatively
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 12 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
5 sites 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 with 3D printed titan custom prothesis in people with Chest Wall Tumors and Post-traumatic Syndrome, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 5 sites in Spain.
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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 Nicolás Moreno Mata MD, PhD, Medicine (0034 647609363, nicolas.moreno.hrc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Respiratory Outcomes: Change from Baseline in Spirometric Parameters Following 3D-Printed Titanium Chest Wall Reconstruction (time frame: From enrollment to the end of treatment at 1 year). The study lists 5 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 12 Aug 2025.