RecruitingOBSERVATIONAL

Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.

This research study is looking into a product called SPRING THREAD® elastic tensor thread. It's designed to help people who have mild to moderate sagging of their facial skin, particularly around the cheekbones and jawline. The main goal is to check how safe and effective this thread is for lifting and firming the skin. Doctors will follow participants for five years to see the long-term results. The study is open to both men and women between 35 and 75 years old. This is a "post-market" study, meaning the thread is already available, but researchers want to gather more information about its performance and safety over a longer period.

At a glance

Status

Recruiting

Sponsor

1st SurgiConcept

Enrolment target

Start

16 Feb 2023

Estimated completion

01 Mar 2029

Ptosis Ptosis, Mild

What is this study about?

This study is all about a special type of thread called SPRING THREAD® elastic tensor thread. It's used in a cosmetic procedure to gently lift and firm parts of the face that might have started to sag a little, like the cheeks and jawline. This sagging is sometimes called 'facial ptosis'. The researchers want to carefully watch how well this thread works and if it's safe for people to use over a long period – five years, to be exact.

The main idea is to see if the thread can effectively improve the look of mild to moderate facial sagging. This isn't a new product to the market, but this study helps doctors and patients understand its long-term performance and safety. It's like checking in on a treatment after it's been introduced to make sure it's doing its job as expected and continues to be a good option.

By taking part, you'd be helping to provide valuable information about this treatment. This information could help future patients and doctors make informed decisions about managing facial sagging. It's an important step in ensuring that treatments like this are both effective and safe for everyone.

Key takeaways

Study examines the safety and effectiveness of SPRING THREAD® for facial sagging.
Aims to lift mild to moderate sagging around cheeks and jawline.
Follow-up will last for five years to see long-term results.
Open to men and women aged 35 to 75.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be a man or a woman aged between 35 and 75 years old. You should have some mild to moderate sagging in your face, particularly around your cheekbones or jawline. It's okay if you've had other cosmetic treatments like Botox, fillers, or even a surgical facelift in the past, as long as it wasn't within the last three months.

It's very important that you can understand what the study involves and be able to follow the instructions given by the study team, including attending all your follow-up appointments. You'll also need to agree to take part and not have any objections once everything has been explained to you.

However, some things might mean you can't join. For example, if you've had a recent facial treatment (within the last 3 months), are taking certain long-term medications (like systemic corticosteroids), or have serious health conditions affecting your organs or immune system. Pregnant or breastfeeding women also can't take part, nor can anyone who is currently in another clinical trial or has been in one very recently.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 35 and 75 years old?
Do you have some mild to moderate sagging of your facial skin?
Can you understand explanations about the study and attend all appointments?
Have you avoided other facial rejuvenation treatments in the last 3 months?
Are you generally healthy and not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the SPRING THREAD® elastic tensor thread treatment. Afterwards, the study team would follow your progress over a period of five years. This will involve several visits to the clinic so that doctors can check how well the treatment is working and make sure you are safe and comfortable. These visits will likely include examinations of your face and discussions about how you feel about the results. The exact number and timing of visits will be explained in detail by the study team. They'll monitor the effects of the thread over time to see its long-term benefits and any changes.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of improving the appearance of facial sagging with the SPRING THREAD® treatment. However, as with any medical procedure, there are potential risks, such as bruising, swelling, discomfort, or other unexpected side effects. The study team will explain all known risks to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Hôpital Henri Mondor
Verified postcode
Créteil, France· Recruiting
Hôpital Henri Mondor
Verified postcode
Créteil, France· Recruiting
Hôpital Pierre Paul Riquet
Verified postcode
Toulouse, France· Not yet recruiting

Common questions

What is facial ptosis?

Facial ptosis is the medical term for sagging skin on the face, often around the cheeks, jawline, or eyebrows.

What is the SPRING THREAD® elastic tensor thread?

It's a special type of flexible thread used to gently lift and support sagging skin on the face to improve its appearance.

How long will the study last?

Researchers will follow participants for five years to see the long-term effects of the treatment.

Will I have to pay to join the study?

Clinical trials generally cover the costs related to the study treatment and visits. This will be confirmed to you by the study team.

What if I change my mind after joining?

You can leave the study at any time you wish, and it won't affect any future medical care you might need.

How to find out more

Dominique MALARD

dom@springthread.com +33 (0)320 23 41 96 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.