NCT06404372

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Sutura Medical Technology LLC · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be a pivotal, blinded, multi-center study to evaluate the safety and effectiveness of Demetech Barbed PDO Suture for the treatment of mid face wrinkles. Subjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 12 months after treatment. Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment. The primary effectiveness endpoint will be determined by the proportion of subjects with ≥1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators. The Lemperle Scale will be used for photographic assessment by the blinded panel. Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator, as well as Investigator- and Subject-rated GAIS, and FACE-Q. Safety will be assessed at each follow-up visit. Subjects will be seen for follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months from treatment.

Conditions

• Wrinkle

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-21
• Primary completion: 2023-12-04
• Completion: 2024-08-07
• First posted: 2024-05-08
• Last updated: 2024-08-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study