Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™ (NCT07144761) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
United States200 participantsStarted 2025-08
Plain-language summary
The objective of this study is to evaluate patient-reported outcomes, surgeon reported outcomes, bruising, symmetry, the success of tissue adhesive for wound closure, and case time.
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
. Subjects with a current Ptosis diagnosis
. Subjects with a history of Graves' Disease
. Subjects with Myasthenia Gravis
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 in overall patient satisfaction - Satisfaction with facial appearance and eyes
Timeframe: From enrollment to the last visit at 3 months
2
Surgeon Satisfaction and Efficiency
Timeframe: From enrollment to the last visit at 3 months.
3
Improvement in Eye Age
Timeframe: From enrollment to the last visit at 3 months.
4
Measure the success of tissue adhesive for wound closure.
Timeframe: From enrollment to the last visit at 3 months.
5
Post-operative ecchymosis
Timeframe: From enrollment to the last visit at 3 months.
6
Eyelid Symmetry
Timeframe: From enrollment to the last visit at 3 months.
7
Improved case time
Timeframe: From enrollment to last visit at 3 months.
. 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.