Status:
RECRUITING
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
Lead Sponsor:
Osheru Inc.
Conditions:
Blepharoplasty
Eligibility:
All Genders
35+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Subjects with a current Ptosis diagnosis
- Subjects with a history of Graves' Disease
- Subjects with Myasthenia Gravis
- 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.
- Active or recent (within 3 months) tobacco user
- Allergy to adhesive glue
- Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
- Pregnant or nursing females.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07144761
Start Date
August 1 2025
End Date
December 1 2025
Last Update
August 27 2025
Active Locations (5)
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1
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
2
Vance Thompson Vision
Alexandria, Minnesota, United States, 56308
3
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
4
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108