Pectus ExcavatumNCT05451108
Pectus Excavatum Camouflage
A study testing PCL Pectus Scaffold implantation and autologous fat grafting in people with Pectus Excavatum, run by BellaSeno Pty Ltd at 1 site in Australia.
Trial summary
The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the… Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- PCL Pectus Scaffold implantation and autologous fat grafting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Dec 2021to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pectus excavatum defect
- Patient aged ≥18 and <55 years (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale)
- Patient willing and able to comply with the study requirements.
- Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- Patient capable of providing valid informed consent.
Who cannot join
- Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
- Patient with known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair.
- Patients with Body Mass Index (BMI) below 18.5 kg/m2 and above 30 kg/m2. NB: Patients with BMI up to 10% higher than the upper limit (up to 33 kg/m2) can be still enrolled if the treating surgeon confirms that BMI is not associated with any kind of pathology.
- Patient with polycaprolactone (PCL) allergy
- Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.
- Women of childbearing potential without an appropriate contraceptive method.
- Patient with life expectancy < 36 months.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Princess Alexandra Hospital - Wooloongabba
Brisbane, Queensland, 4102
About this study
Official title: A Clinical Trial Evaluating Medical-Grade Polycaprolactone-PCL Pectus Scaffold Implantation With Autologous Fat Grafting for Pectus Excavatum Camouflage
The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes.
The implanted scaffold acts as absorbable frame to support the growth of cells. The substance used for the scaffold is absorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.
Read the detailed description
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted to correct pectus excavatum defects. First the patient will be thoroughly evaluated with history taking, examination and medical imaging to determine whether they are suitable for implantation. Imaging will take place as part of the work-up for the trial in the form of a CT scan and MRI. If the patient is deemed suitable for the trial, a custom-made scaffold for the patient chest wall defect is designed based on the medical imaging attained previously. This scaffold is then manufactured and sterilised, before being implanted.
The implantation surgery will be done at a tertiary teaching hospital by an experienced plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques, usually from the abdomen and thighs depending on the availability of the tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of implantation. The total length of procedure is estimated to take 1 hour.
The patients progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as recurrent MRI studies.
The effectiveness, complications and side-effects will be monitored for up to two years.
All appointments and clinical assessment will be documented in the electronic patient medical record as well as a secure de-identified trial database.
- Conditions
- Pectus Excavatum
- Being tested
- PCL Pectus Scaffold implantation and autologous fat grafting
- Keywords
- PCL Scaffold, Absorbable Implant, Regenerative Medicine, Pectus Excavatum Camouflage
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCL Pectus Scaffold implantation and autologous fat graftingDevice
A small incision is made in the chest and pre-sternal pocked is defined. Following this, an empty scaffold is implanted at the site of the defect with skin closed directly over it. At the same stage, autologous fat transfer will be performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The area will be infiltrated with local anaesthetic tumescent fluid, liposuction performed, and fat transferred to syringes for filtration prior to injection into the scaffold. Fat will not be processed beyond simple filtration to separate liquid from fat to be injected. The scaffold provides structural stability to the chest during the infiltration of the tissue inside the scaffold.
| Study group | Role | What they receive |
|---|---|---|
| Insertion of PCL Pectus scaffold | Experimental | Insertion of a custom-made 3D printed medical-grade polycaprolactone (PCL) Pectus scaffold with autologous fat graft for pectus excavatum defect correction. Receives: Device: PCL Pectus Scaffold implantation and autologous fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of occurrence and type of SADE and AEs related to the surgical procedure or the device (e.g. vital signs, physical exam findings and cardiorespiratory function from baseline to end of study visit) to ensure the safety of device and procedure.
Clinical safety will be assessed by documenting all adverse events regardless of whether they are related to the trial in an adverse events report form - described in detail in the case report form (CRF). These will be carefully evaluated by the principal investigator.
Measured: Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 18-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.
Secondary outcomes (5)
Change in (fat) volume, soft tissue retention and tissue integration from the time of surgery to the end of study visit using radiological and clinical assessments
Fat volume, soft tissue retention and tissue integration will be evaluated by a senior radiologist utilising serial MRI imaging with assessment of soft tissue volume using a standardised segmentation protocol. Imaging will be taken at regular intervals in conjunction with clinical visits as defined by the protocol.
Measured: Assessed pre-surgery and at 1-,3-,6-,12-,18- and 24-months post-surgery.
Change in cardiorespiratory function from baseline to 1 month after surgery
Pre-operative exercise tolerance testing to confirm their suitability for the trial. This will be repeated after complete recovery from the operation (usually after >4 weeks).
Cardiorespiratory outcome will be assessed using baseline and post-operative cardiopulmonary exercise. Standard Cardio-Pulmonary Exercise Testing (CPET) protocol will be applied and validated by a physician.
Measured: Assessed pre-surgery and at 1-month post-surgery.
Change in pain assessments from baseline to the end of study visit
Pain will be assessed with the numerical pain rating system from 0 (no pain at all) to 10 (worst imaginable pain). It will be tracked in the inpatient setting as well as at post-operative outpatient reviews.
Measured: Assessed pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12-,18- and 24-months and any relevant unscheduled visits post-surgery.
Change in wound healing from the time of surgery to 1 month after surgery
Wound status will be assessed with the Holger Classification for wounds.
Measured: Assessed during inpatient stay and at 1-week and at 1-month post-surgery.
Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit
The Nuss questionnaire modified for adults (NQ-mA) and the 36-item Short Form Quality of Life (SF-36) questionnaire will be used to assess patient reported functional outcomes from the intervention. A combination of the NQ-mA and the SF-36 questionnaires provides a platform for comparison of the method proposed in this study against the current gold standard surgical management of pectus excavatum, as well as measuring the relative impact on health-related quality of live compared to interventions in other clinical scenarios.
Measured: Assessed pre-surgery and at the 3-, 6-, 12-,18- and 24-month clinical reviews.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 Dec 2021
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- BellaSeno Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Wagels, Dr, Principal investigator, Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451108
- Sponsor's protocol ID
- 2020-PEC-001
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating Medical-Grade Polycaprolactone-PCL Pectus Scaffold Implantation With Autologous Fat Grafting for Pectus Excavatum Camouflage
- ClinicalTrials.gov ID
- NCT05451108
- Acronym / sponsor ID
- 2020-PEC-001
- Conditions
- Pectus Excavatum
- Keywords
- PCL Scaffold, Absorbable Implant, Regenerative Medicine, Pectus Excavatum Camouflage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BellaSeno Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 11 Jul 2022 (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.
The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes.
The implanted scaffold acts as absorbable frame to support the growth of cells. The substance used for the scaffold is absorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.
Detailed description
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted to correct pectus excavatum defects. First the patient will be thoroughly evaluated with history taking, examination and medical imaging to determine whether they are suitable for implantation. Imaging will take place as part of the work-up for the trial in the form of a CT scan and MRI. If the patient is deemed suitable for the trial, a custom-made scaffold for the patient chest wall defect is designed based on the medical imaging attained previously. This scaffold is then manufactured and sterilised, before being implanted.
The implantation surgery will be done at a tertiary teaching hospital by an experienced plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques, usually from the abdomen and thighs depending on the availability of the tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of implantation. The total length of procedure is estimated to take 1 hour.
The patients progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as recurrent MRI studies.
The effectiveness, complications and side-effects will be monitored for up to two years.
All appointments and clinical assessment will be documented in the electronic patient medical record as well as a secure de-identified trial database.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insertion of PCL Pectus scaffold | Experimental | Device: PCL Pectus Scaffold implantation and autologous fat graftingInsertion of a custom-made 3D printed medical-grade polycaprolactone (PCL) Pectus scaffold with autologous fat graft for pectus excavatum defect correction. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pectus excavatum defect
- Patient aged ≥18 and <55 years (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale)
- Patient willing and able to comply with the study requirements.
- Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- Patient capable of providing valid informed consent.
Key exclusion criteria (8 listed)
- Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
- Patient with known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair.
- Patients with Body Mass Index (BMI) below 18.5 kg/m2 and above 30 kg/m2. NB: Patients with BMI up to 10% higher than the upper limit (up to 33 kg/m2) can be still enrolled if the treating surgeon confirms that BMI is not associated with any kind of pathology.
- Patient with polycaprolactone (PCL) allergy
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 |
|---|---|---|
| PCL Pectus Scaffold implantation and autologous fat graftingA small incision is made in the chest and pre-sternal pocked is defined. Following this, an empty scaffold is implanted at the site of the defect with skin closed directly over it. At the same stage, autologous fat transfer will be performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The area will be infiltrated with local anaesthetic tumescent fluid, liposuction performed, and fat transferred to syringes for filtration prior to injection into the scaffold. Fat will not be processed beyond simple filtration to separate liquid from fat to be injected. The scaffold provides structural stability to the chest during the infiltration of the tissue inside the scaffold. | Device | Insertion of PCL Pectus scaffold |
Primary outcome
Assessment of occurrence and type of SADE and AEs related to the surgical procedure or the device (e.g. vital signs, physical exam findings and cardiorespiratory function from baseline to end of study visit) to ensure the safety of device and procedure.
Time frame: Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 18-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.
Clinical safety will be assessed by documenting all adverse events regardless of whether they are related to the trial in an adverse events report form - described in detail in the case report form (CRF). These will be carefully evaluated by the principal investigator.
5 secondary outcomes
Change in (fat) volume, soft tissue retention and tissue integration from the time of surgery to the end of study visit using radiological and clinical assessments
Time frame: Assessed pre-surgery and at 1-,3-,6-,12-,18- and 24-months post-surgery.
Change in cardiorespiratory function from baseline to 1 month after surgery
Time frame: Assessed pre-surgery and at 1-month post-surgery.
Change in pain assessments from baseline to the end of study visit
Time frame: Assessed pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12-,18- and 24-months and any relevant unscheduled visits post-surgery.
Change in wound healing from the time of surgery to 1 month after surgery
Time frame: Assessed during inpatient stay and at 1-week and at 1-month post-surgery.
Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit
Time frame: Assessed pre-surgery and at the 3-, 6-, 12-,18- and 24-month clinical reviews.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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. This study is not recruiting at the moment.
Michael Wagels, Dr principal investigator
Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCL Pectus Scaffold implantation and autologous fat grafting in people with Pectus Excavatum, run by BellaSeno Pty Ltd at 1 site in Australia.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jul 2026. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of occurrence and type of SADE and AEs related to the surgical procedure or the device (e.g. vital signs, physical exam findings and cardiorespiratory function from baseline to end of study visit) to ensure the safety of device and procedure. (time frame: Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 18-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.). 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 10 Jul 2026.