Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06404372
NA

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

Sponsor: Sutura Medical Technology LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2022-07-18

Completion Date

2024-07-30

Last Updated

2026-08-11

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Demetech Barbed PDO Suture

The Demetech Barbed PDO Suture will be used for the correction of midface wrinkles in all patients enrolled in this study.

Locations (4)

Rejuva Medical Aesthetics

Los Angeles, California, United States

Cosmetic Injectables Center

Sherman Oaks, California, United States

Vedas Med Spa

The Woodlands, Texas, United States

Dr. Kristin Tarbet Facial Plastic Surgery

Bellevue, Washington, United States