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

NCT06404372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

  • Wrinkle

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.

Sponsors & Collaborators

  • Sutura Medical Technology LLC

    lead INDUSTRY

Principal Investigators

  • Sherly Soleiman, MD · Cosmetic Injectables Center

  • Chaitali Nangrani, MD · Vedas Med Spa

  • Kristin Tarbet, MD · Dr. Kristin Tarbet Facial Plastic Surgery

  • Amit Kocher, MD · Rejuva Medical Aesthetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2023-12-04
Completion
2024-08-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06404372 on ClinicalTrials.gov