The ongoing clinical trial aims to evaluate the safety and performance of the “Infinite-Thread®” Permanent Tensor Thread for facial tissue elevation. Organized by Thread and Lift, with support from EVAMED, this research could have significant implications for the medical device industry and aesthetic treatments.
In this article:
- What is the study about?
- Why does this matter?
- FAQs about the trial
- Key takeaways
- Disclaimer
- Full information
What is the study about?
The clinical trial, recorded as NCT07195877 on ClinicalTrials.gov, focuses on evaluating the “Infinite-Thread®” as a permanent tensor thread specifically intended for facial tissue elevation. The device is placed via minimally invasive techniques, and the study aims to verify its long-term safety and therapeutic performance in real-life conditions. Recruitment for participation is ongoing.
Sponsored by Thread and Lift, a company specializing in advanced aesthetic solutions, and supported by EVAMED’s clinical expertise, the study reflects a growing trend of expanded real-world evidence requirements for medical device development.
Why does this matter?
Facial tissue elevation is a critical procedure in aesthetics and reconstructive treatments. Devices like the “Infinite-Thread®” address the increasing demand for non-invasive solutions, but they must prove both safety and effectiveness under MDR (Medical Device Regulation) frameworks.
This type of study aligns with regulatory priorities, ensuring quality management and post-market surveillance data. The findings of the trial will likely impact how tensor thread technologies advance standard clinical practices and could influence regulatory decision processes for future innovations.
Moreover, this trial directly supports optimization strategies for medical professionals who rely on verified tools in their practices.
FAQs about the trial
Q1: What are tensor threads?
Tension or tensor threads are medical devices designed to elevate or reposition tissues, improving structural integrity and aesthetic appearance.
Q2: How is safety measured?
The trial will assess outcomes such as adverse events, infection rates, and tissue reactions while ensuring compliance with regulatory standards.
Q3: Who can participate?
Eligible individuals for this study are recruited under specific conditions to ensure accuracy in findings. The details can be found on the ClinicalTrials.gov page.
Key takeaways
This clinical trial represents an essential step forward for aesthetic medical devices, focusing on evidence-based validation. It enables manufacturers and regulatory teams to better define the capabilities of tensor thread devices, ensuring they meet the requirements for both safety and effectiveness.
Interested stakeholders, including clinical practitioners and manufacturers, should monitor the progress closely as it could have widespread implications for ongoing device certification processes.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or professional advice. Readers should consult regulatory experts for guidance on compliance with MDR or other applicable standards.
Full information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07195877?term=medical+device