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Pectus Excavatum Camouflage (IT)

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion moved earlier from Nov 2027 to Dec 2026
    • Secondary endpoints expanded, about 151 words
    v5
  2. Primary completion date: Jan 1, 2026 to Nov 2027v4 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 1, 2026 to Nov 2027
    • Start date: Dec 14, 2022 to Dec 28, 2022
    • Site details revised
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 5, 2022 to Dec 14, 2022
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 absorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.
Trial Details
NCT Number NCT05634070
Lead Sponsor BellaSeno GmbH
Conditions
(from sponsor)		 Pectus Excavatum
Related terms Funnel Chest
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov