Pectus Excavatum Camouflage (IT)

NCT05634070 | Active Not Recruiting DMC

• 1 other identifier: 2021-PEC-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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 resorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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)

  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

  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.

  Assessed at 3, 6, 12 and 24 month - clinical review

Other Outcomes (1)

• Observational assessment of health economic measures from the time of surgery to the end of study visit

  Assessed at 24 post-surgery months

Study Arms (1)

Insertion of a custom-made 3D printed medical-grade polycaprolactone scaffold

EXPERIMENTAL

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

Interventions

PCL Pectus scaffold implantation and autologous fat grafting DEVICE

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.

Insertion of a custom-made 3D printed medical-grade polycaprolactone scaffold

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Genetic female patients of age 14 years and up OR Genetic male patients of age 16 years and up without cardiopulmonary compromise seeking correction or improvement of pectus excavatum-associated with anterior chest wall deformity and/or congenital defect.
• Patient willing and able to comply with the study requirements (e.g., all scheduled appointments).
• Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia).
• Patient and his/her parents/legal guardian (in case of minor patients) capable of providing valid written informed consent.
• Have sufficient body fat for homologous transplantation.
• The patient/Guardian has "realistic" expectations of surgical results as determined by the PI.

You may not qualify if:

• Genetic females less than 14 years of age at the time of surgery.
• Genetic males less than 16 years of age at the time of surgery.
• Active infection anywhere in the body.
• Patient chest wall tissue is clinically incompatible for the procedure as determined by PI.
• Compromised vascularity in the pectoralis muscle and subcutaneous tissue.
• Patient and is/her parents/legal guardian (in case of minor patients) unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
• Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.
• 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 Co-ordinating 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 still requiring functional repair.
• Body mass Index (BMI below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).
• Female patients who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.
• Female patients of childbearing potential without an appropriate contraceptive method.
• Patient ineligible to undergo MRI.
• Patient life expectancy \< 36 months.
• Patient unable or unwilling to comply with the treatment protocol.

Sponsors & Collaborators

• BellaSeno GmbH: lead

Study Sites (1)

Meyer Children's Univeristy Hospital

Florence, Italy, 50139, Italy

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Flavio Facchini, Dr

  Unit of Paediatric Surgery and Burn Center - Meyer Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 1, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)