Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation (NCT07250139) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
United States50 participantsStarted 2025-12-08
Plain-language summary
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft, allowing a direct side-by-side comparison.
The objectives of the study are to compare Ziplyft treatment vs. traditional surgery by evaluating bruising, wound closure and incision, surgery case time, and subject/surgeon surveys.
Who can participate
Age range
35 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
. Provide signed written consent prior to participation in any study-related procedures.
. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
. Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Exclusion criteria
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
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
Timeframe: From the beginning of the surgical case until surgery has been completed
2
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
Timeframe: 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)
3
Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.
Timeframe: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
4
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
Timeframe: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
5
Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty
Timeframe: The day of surgery until 2 months (± 1 month) post-operation
. Subjects that in the opinion of the investigator are anatomically not conducive to using devices (e.g., heavy brow, severe hollowing of the upper eyelid, history of ocular or orbital trauma).
. Subjects that have had any previous surgery eyelid or eyebrow region.
. Use of anticoagulation therapy, including, but not limited to Aspirin, NSAIDS, Ibuprofen within 7 days and Xarelto, Warfarin, Enoxaparin, Plavix within 3 days prior to planned study procedure.