Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Osheru Inc.

Status: Enrolling

Conditions: Blepharoplasty

Treatments: Device: Ziplyft

Study type: Interventional

Funder types: Industry

Identifiers

NCT07144761

6520-Osheru

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provide signed written consent prior to participation in any study-related procedures.
2. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
3. Male or female adults, ≥ 35 years old at the Preoperative Visit
4. Willing to return for required follow-up visits.
5. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
6. 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

1. Subjects with a current Ptosis diagnosis
2. Subjects with a history of Graves' Disease
3. Subjects with Myasthenia Gravis
4. 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).
5. Subjects that have had any previous surgery eyelid or eyebrow region.
6. 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.
7. Active or recent (within 3 months) tobacco user
8. Allergy to adhesive glue
9. 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.
10. Pregnant or nursing females.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Ziplyft Device

Experimental group

Description:

Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin.

Treatment:

Device: Ziplyft