Pectus Excavatum Camouflage

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted to correct pectus excavatum defects. First the patient will be thoroughly evaluated with history taking, examination and medical imaging to determine whether they are suitable for implantation. Imaging will take place as part of the work-up for the trial in the form of a CT scan and MRI. If the patient is deemed suitable for the trial, a custom-made scaffold for the patient chest wall defect is designed based on the medical imaging attained previously. This scaffold is then manufactured and sterilised, before being implanted. The implantation surgery will be done at a tertiary teaching hospital by an experienced plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction techniques, usually from the abdomen and thighs depending on the availability of the tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of implantation. The total length of procedure is estimated to take 1 hour. The patients progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as recurrent MRI studies. The effectiveness, complications and side-effects will be monitored for up to two years. All appointments and clinical assessment will be documented in the electronic patient medical record as well as a secure de-identified trial database. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05451108
Study type	Interventional
Source	BellaSeno GmbH
Contact	Michael Wagels, Dr
Phone	+61406183619
Email	michael.wagels@health.qld.gov.au
Status	Recruiting
Phase	N/A
Start date	December 10, 2021
Completion date	March 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05034601` - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure	N/A
Completed	`NCT02552186` - Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus	N/A
Recruiting	`NCT04167865` - Effects of Exercise Therapy on Pectus Excavatum	N/A
Completed	`NCT05443113` - Young Pectus Excavatum Patients and Genetic Defects
Completed	`NCT04362878` - Psychological Assessment of Patients With Chest Wall Deformities
Recruiting	`NCT06110689` - Capturing Physiologic Autonomic Data From Clinically Indicated Magnetic Resonance Imaging Scans in Children
Completed	`NCT02009267` - Nuss Procedure: Clinical Options in Pediatric Pain Management?	N/A
Recruiting	`NCT01486953` - Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum	Phase 4
Completed	`NCT02169297` - Sub-Paraspinal Block in Nuss Patients. A Pilot Project	Phase 4
Completed	`NCT02174796` - Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities	N/A
Recruiting	`NCT04211935` - Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum	N/A
Completed	`NCT02721017` - Cryoanalgesia vs. Epidural in the Nuss Procedure	Phase 4
Completed	`NCT02337621` - Pain, Exercise and Psychological Well-being in Pectus Excavatum
Terminated	`NCT01863498` - Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA	N/A
Recruiting	`NCT04418583` - Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging	N/A
Active, not recruiting	`NCT05063695` - Pectus ESC Outcomes and Comparative Effectiveness Study
Completed	`NCT01816373` - Non-invasive Negative Pressure Treatment for Pectus Excavatum	N/A
Withdrawn	`NCT02376634` - Hypnotherapy in Major Surgical Procedures	N/A
Not yet recruiting	`NCT06436755` - Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery
Completed	`NCT02163265` - Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Functions	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.