Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Blepharoplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ziplyft Device

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

Group Type EXPERIMENTAL

Ziplyft

Intervention Type DEVICE

Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.

Interventions

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Ziplyft

Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No