Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation

Part of paid clinical trials in Oxford, North Carolina.

Sponsor
Osheru Inc.
Study ID
NCT07250139
Status
Recruiting

Conditions

  • Blepharoplasty
  • Dermatochalasis of Upper Eyelid
  • Ptosis, Eyelid

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziplyft Device — DEVICE
    Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Ziplyft compresses the excess skin and seals it together, no suturing is required, and the surgery incision will be closed with tissue adhesive.
  • Comparator Arm: Standard Blepharoplasty — OTHER
    Standard blepharoplasty will be used on the fellow side of the participant's face. Standard blepharoplasty uses a blade, cautery to seal blood vessels, and sutures to close the incision.

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Comparing Ziplyft Device Treatment to Standard Blepharoplasty
    Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Standard blepharoplasty will be performed on the fellow side of the participant's face.

Primary Outcome Measure

Compare surgical case time for Ziplyft treatment versus standard blepharoplasty [ Time Frame: From the beginning of the surgical case until surgery has been completed ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New Century OphthalmologyOxfordNorth Carolina27585
Sumeet Jindal, MD, MBA
919-375-2259
Sumeet Jindal, MD (PRINCIPAL_INVESTIGATOR)

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