An interventional study of PCL Pectus scaffold implantation and autologous fat grafting in Pectus Excavatum, sponsored by BellaSeno GmbH. Active, not recruiting at 1 site in Italy. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by BellaSeno GmbH · Not applicable, Interventional, and Other
The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function.
The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and absorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.
A 3D printed custom-made scaffold made of medical-grade polycaprolactone (m-PCL) is planned to be implanted to correct pectus excavatum defects.
Participants will be recruited at the Meyer Hospital (Florence, Italy). The patient is assessed clinically by the PI with a direct history and examination, in conjunction with the imaging reviewed by the Principal Investigator and his team. Imaging is organised through the Meyer Hospital imaging department and includes chest CT and MRI. Patients will be formally enrolled into the trial after written informed consent is obtained from the patients and from their parents/legal guardian (in case of minor patients). If the patient is deemed suitable and satisfy the inclusion and exclusion criteria, as assessed by the Principal Investigator and his team, a custom-made scaffold is designed based on his/her medical-imaging.
The procedure for implantation of the scaffold is similar to the procedure for implantation of silicone implants. A small incision is made in the chest, a pre-sternal pocked is defined, following this an empty scaffold is implanted at the site of the defect (pectus excavatum) with skin closed directly over it. At the same intervention, autologous fat transfer is performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The scaffold provides structural stability to the infiltration of the tissue inside the scaffold. Once the scaffold is fully absorbed, the tissue, which infiltrated it is expected to provide structural stability to the void defect and potentially ensuring a stable outcome.
After the scaffold implantation and fat grafting procedure, patients will remain an inpatient for the necessary number of days after the surgery. In uncomplicated cases, patients will be reviewed at trial required follow up visits at 1, 3-, 6-, 12- and 24-months post-surgery. Each follow up visit will include routine clinical assessments, review of adverse events and medications, repeat MRI scans and completion of questionnaires for the patients. The focus of these assessments is to identify complications, while establishing clinical and radiological evidence of soft tissue retention.
All appointments and clinical assessment will be documented in the patient medical record.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Insertion of a custom-made 3D printed medical-grade polycaprolactone scaffold in the thorax region with autologous fat graft to camouflage pectus excavatum defect.
Device: PCL Pectus scaffold implantation and autologous fat grafting
A suitable incision will be made using a scalpel and diathermy following standard surgical procedures.The implant pocket shall be rinsed with saline. The PCL Pectus Scaffold shall be inserted into the pocket following the Instruction for Use and fixed to the thoracic wall using 2 to 4 sutures. The device shall not be modified for any patient in any manner. The incision shall be closed using 2-0 Vicryl or Monocryl and 3-0 Monocryl sutures, if applicable. Number of layers to be sutured will be decided by the PI for each patient. Sterile bandaging as well as Steri-Strips shall be applied on the sutures. A prophylactic antibiotic such as Cefazolin 1g (3 shots per day x 2 days) shall be administered to the patient. In case the patient has Cefazolin allergy, Clindamycin 600 mg shall be prescribed. Autologous Fat Grafting procedure shall be performed immediately after implantation. The patients shall be hospitalized for the necessary number of days under clinical observation.
Rate of adverse events and serious adverse events from the time of surgery to the end of study visit.
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.
Time frame: Assessed at 24 post-surgery months
Change in (fat) volume % and soft tissue retention % within the scaffold (radiological and/or clinical) from the time of surgery to the end of study visit using radiological and clinical assessments
Soft tissue retention will be evaluated utilising serial MRI imaging with assessment of soft tissue volume using a standardised segmentation protocol by a senior radiologist. Imaging will be taken at regular intervals in conjunction with clinical visits as defined by the protocol.
Time frame: Assessed at 1-,6-,12-,24-months post-surgery
Preservation of pre-operative functional status
All patients prospectively enrolled in the trial will undergo pre-operative exercise tolerance testing to confirm their suitability for the trial. This is a standard test that each patient with Pectus Excavatum undergoes before any surgical operation. This will be repeated after complete recover from the operation (after 12 months) to evaluate whether the intervention has affected the patient's functional status. Standard cardiopulmonary exercise testing (CPET) protocol will be applied and validated by a physician.
Time frame: Assessed at 12-months 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)
Time frame: Assessed at 1-month post surgery
Change in wound healing from the time of surgery to the end of study visit
Wound status will be assessed with the Holger Classification for wounds
Time frame: Assessed 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 validated Italian translation of the 36-item Short Form Quality of Life (SF-36) questionnaire, a patient-reported survey of patient health, will be used to assess patient reported functional outcomes from the intervention. It consists of eight scaled scores (physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, social role functioning, emotional well-being, bodily pain, general health perceptions), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100: the lower the score the more disability, the higher the score the less disability (a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). The SF-36 questionnaire will be administered pre-operation and post-operation.
Time frame: Assessed at 3, 6, 12 and 24 month - clinical review
Observational assessment of health economic measures from the time of surgery to the end of study visit
Length of admission (measured in days). It will be monitored to provide a guide for optimisation of current protocols and potential translation into use of PCL scaffolds for reconstruction in broader clinical settings.
Time frame: Assessed at 24 post-surgery months
Observational assessment of health economic measures from the time of surgery to the end of study visit
Infrastructure costs (measured in euro). These will be monitored throughout the trial to provide a guide for optimisation of current protocols and potential translation into use of PCL scaffolds for reconstruction in broader clinical settings.
Time frame: Assessed at 24 post-surgery months
Observational assessment of health economic measures from the time of surgery to the end of study visit
Operative time (measured in minutes). It will be monitored to provide a guide for optimisation of current protocols and potential translation into use of PCL scaffolds for reconstruction in broader clinical settings.
Time frame: Assessed at 24 post-surgery months
Observational assessment of histological measures following secondary autologous fat graft (AFG) if indicated (general tissue morphology and micropathology, adipose tissue viability, angiogenesis and immune activity)
If patients undergo subsequent fat grafting, core biopsy samples will be taken to histologically evaluate the scaffold contents. Specific stains will be used to assess tissue morphology (haematoxylin and eosin and Oli-Red), that can be correlated with medical imaging, as well as previous data gained from pre-clinical animal models.
Time frame: Assessed at 24-months post-surgery.
Observational assessment of histological measures following secondary autologous fat graft (AFG) if indicated (general tissue morphology and micropathology, adipose tissue viability, angiogenesis and immune activity)
If patients undergo subsequent fat grafting, core biopsy samples will be taken to histologically evaluate the scaffold contents. Specific stains will be used to assess adipose tissue viability (anti-Perilipin), that can be correlated with medical imaging, as well as previous data gained from pre-clinical animal models.
Time frame: Assessed at 24-months post-surgery.
Observational assessment of histological measures following secondary autologous fat graft (AFG) if indicated (general tissue morphology and micropathology, adipose tissue viability, angiogenesis and immune activity)
If patients undergo subsequent fat grafting, core biopsy samples will be taken to histologically evaluate the scaffold contents. Specific stains will be used to assess angiogenesis (anti-von Willebrand Factor/CD 31), that can be correlated with medical imaging, as well as previous data gained from pre-clinical animal models.
Time frame: Assessed at 24-months post-surgery.
Observational assessment of histological measures following secondary autologous fat graft (AFG) if indicated (general tissue morphology and micropathology, adipose tissue viability, angiogenesis and immune activity)
If patients undergo subsequent fat grafting, core biopsy samples will be taken to histologically evaluate the scaffold contents. Specific stains will be used to assess immune activity (M1 and M2 macrophage activity), that can be correlated with medical imaging, as well as previous data gained from pre-clinical animal models.
Time frame: Assessed at 24-months post-surgery.
Plan to share: No
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