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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05451108




Registration number
NCT05451108
Ethics application status
Date submitted
30/06/2022
Date registered
11/07/2022
Date last updated
10/01/2024

Titles & IDs
Public title
Pectus Excavatum Camouflage
Scientific title
A Clinical Trial Evaluating Medical-Grade Polycaprolactone-PCL Pectus Scaffold Implantation With Autologous Fat Grafting for Pectus Excavatum Camouflage
Secondary ID [1] 0 0
2020-PEC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pectus Excavatum 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PCL Pectus Scaffold implantation and autologous fat grafting

Experimental: Insertion of PCL Pectus scaffold - Insertion of a custom-made 3D printed medical-grade polycaprolactone (PCL) Pectus scaffold with autologous fat graft for pectus excavatum defect correction.


Treatment: Devices: PCL Pectus Scaffold implantation and autologous fat grafting
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in adverse events, concomitant medications, vital signs, physical exam findings and cardiorespiratory function from baseline to the end of study visit.
Timepoint [1] 0 0
Assessed at 24-months post-surgery.
Secondary outcome [1] 0 0
Change in (fat) volume % and soft tissue retention % from the time of surgery to the end of study visit using radiological and clinical assessments
Timepoint [1] 0 0
Assessed at 1-,3-,6-,12- and 24-months post-surgery with 2 years post surgery being the primary time-point.
Secondary outcome [2] 0 0
Change in cardiorespiratory function from baseline to 1 month after surgery
Timepoint [2] 0 0
Assessed at 1-month post-surgery
Secondary outcome [3] 0 0
Change in pain assessments from baseline to the end of study visit
Timepoint [3] 0 0
Assessed at 1-month post-surgery
Secondary outcome [4] 0 0
Change in wound healing from the time of surgery to the end of study visit
Timepoint [4] 0 0
Assessed at 1-month post-surgery
Secondary outcome [5] 0 0
Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit
Timepoint [5] 0 0
Assessed at the 3-, 6-, 12- and 24-month clinical reviews

Eligibility
Key inclusion criteria
1. Pectus excavatum defect

2. Patient aged =18 and <55 years (patients 55 years and over may still be eligible
pending assessment by investigating team and documentation of rationale)

3. Patient willing and able to comply with the study requirements.

4. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal
devices, no history of severe claustrophobia).

5. Patient capable of providing valid informed consent.
Minimum age
18 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with a known history of immunodeficiency including HIV, concomitant systemic
corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other
cause for secondary/primary immunodeficiency.

2. 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.

3. Patient with unstable cardiac or respiratory function due to pectus excavatum or those
requiring functional repair.

4. Patient with body mass index (BMI) below 20 and above 30 kg/m2 (patients with a BMI
above 30 kg/m2 may still be eligible pending assessment by investigating team and
documentation of rationale).

5. Patient with polycaprolactone (PCL) allergy

6. Women who are currently pregnant or breast feeding, or who are planning to become
pregnant within two years after the pectus excavatum camouflage surgery.

7. Women of childbearing potential without an appropriate contraceptive method.

8. Patient ineligible to undergo MRI.

9. Patient with life expectancy < 36 months.

10. Patient unable or unwilling to comply with the treatment protocol.

11. Patient unwilling or unable to provide fully informed consent including but not
limited to patients with intellectual or mental impairment.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Wooloongabba - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BellaSeno Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05451108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Wagels, Dr
Address 0 0
Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Wagels, Dr
Address 0 0
Country 0 0
Phone 0 0
+61406183619
Fax 0 0
Email 0 0
michael.wagels@health.qld.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05451108