Pectus Excavatum Camouflage

NCT05451108 | Active Not Recruiting DMC

• 1 other identifier: 2020-PEC-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 patient's chest using the body's natural healing processes. The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, 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.

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 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

  Assessed pre-surgery and at 1-,3-,6-,12- and 24-months post-surgery.

• Change in cardiorespiratory function from baseline to 1 month after surgery

  Assessed pre-surgery and at 1-month post-surgery.

• Change in pain assessments from baseline to the end of study visit

  Assessed pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12- and 24-months and any relevant unscheduled visits post-surgery.

• Change in wound healing from the time of surgery to 1 month after surgery

  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

  Assessed pre-surgery and at the 3-, 6-, 12- and 24-month clinical reviews.

Other Outcomes (3)

• Observational assessment of health economic measures from the time of surgery to the end of study visit (hospital length of stay, ICU length of stay, operative time, blood loss during surgery (mL))

  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)

  Assessed at 24-months post-surgery.

• Observational and descriptive assessment of clinical photographs, videos and 3D surface scan of the upper torso and chest fields from the time of surgery to the end of study visit

  Assessed pre-surgery and at 1-week, at 1-,3-,6-,12- and 24-months post-surgery.

Study Arms (1)

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.

Device: PCL Pectus Scaffold implantation and autologous fat grafting

Interventions

PCL Pectus Scaffold implantation and autologous fat grafting DEVICE

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.

Insertion of PCL Pectus scaffold

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BellaSeno Pty Ltd: lead

Study Sites (1)

Princess Alexandra Hospital - Wooloongabba

Brisbane, Queensland, 4102, Australia

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

• Michael Wagels, Dr

  Department of Plastic & Reconstructive Surgery Princess Alexandra 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: June 30, 2022
• First Posted: July 11, 2022
• Study Start: December 14, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)