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First received: May 03, 2024

Clinical Trial: To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Wrinkle

Study Type: INTERVENTIONAL


Official Title: A Pivotal, Blinded Multi-Center Study to Show the Safety and Effectiveness of the Demetech Barbed PDO Suture

Brief Summary: The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles.The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale.Primary endpoints include assessing the rate of adverse…

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