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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05451108
Ethics application status
Date submitted
30/06/2022
Date registered
11/07/2022

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
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.
Timepoint [1] 0 0
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 outcome [1] 0 0
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
Timepoint [1] 0 0
Assessed pre-surgery and at 1-,3-,6-,12- and 24-months post-surgery.
Secondary outcome [2] 0 0
Change in cardiorespiratory function from baseline to 1 month after surgery
Timepoint [2] 0 0
Assessed pre-surgery and 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 pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12- and 24-months and any relevant unscheduled visits post-surgery.
Secondary outcome [4] 0 0
Change in wound healing from the time of surgery to 1 month after surgery
Timepoint [4] 0 0
Assessed during inpatient stay and at 1-week and 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 pre-surgery and 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. 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.
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 with life expectancy < 36 months.

Study design
Purpose of the study
Other
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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
Accrual to date
Final
7
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05451108