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

Wrinkle Clinical Trial

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

Clinical Trial 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 events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06404372
Study type Interventional
Source Sutura Medical Technology LLC
Contact
Status Active, not recruiting
Phase N/A
Start date April 21, 2022
Completion date June 2024
View Details
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