To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture (NCT06404372) | Clinical Trial Compass
CompletedNot Applicable
To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture
United States57 participantsStarted 2022-07-18
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects, 22+ years of age.
. Subject received a rating, in each cheek, by PI of at least Class 1 or more for wrinkling in the midface according to the Lemperle Scale Classification of Facial Wrinkling.
. If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must have a confirmed negative urine pregnancy test result at screening. If treatment is not provided at the screening visit, a negative urine pregnancy test result is required within 7 days before treatment.
. If a woman of childbearing potential, subject confirms she will utilize at least one form of contraception throughout the duration of the study.
. Subjects who desire cheek lifting to correct age-related wrinkles in the midface as recommended by the treating investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement From Baseline on the Lemperle Classification Wrinkle Scale
. Subjects who are able to understand the study requirements, including the obligation not to receive any other facial procedures or treatments affecting mid-face at any time during the study.
. Subjects who are willing to participate in the study and to sign a witnessed/informed consent form.
. Subjects who are logistically able to present for all study visits and meet all study requirements.
Exclusion criteria
. Abnormal rating in midface sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the midface.
. Active acne or prominent acne scars in the treatment area.
. Active inflammatory or infectious conditions.
. Allergy or foreign body sensitivities to plastic biomaterials.
. Known bleeding disorder.
. Breastfeeding, pregnant, or not on/willing to use contraception if of childbearing potential.