Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Part of paid clinical trials in Miami, Florida.

Sponsor
Osheru Inc.
Study ID
NCT07144761
Status
Recruiting
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Conditions

  • Blepharoplasty

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

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

Primary Outcome Measure

Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes [ Time Frame: From enrollment to the last visit at 3 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Center for Excellence in Eye CareMiamiFlorida33176
Elizabeth Vargas
[email protected]
305-598-2020
Ana C Victoria, MD (PRINCIPAL_INVESTIGATOR)
Vance Thompson VisionAlexandriaMinnesota56308
Tiffany Facile, MBA
[email protected]
605-254-7126
Deborah Ristvedt, DO (PRINCIPAL_INVESTIGATOR)
Eye Care SpecialistsKingstonPennsylvania18704
Patti Meyers
[email protected]
570-714-5910
Richard Roth, MD (PRINCIPAL_INVESTIGATOR)
Vance Thompson VisionSioux FallsSouth Dakota57108
Tiffany Facile, MBA
[email protected]
605-254-7126
Zachary Keenum, MD (PRINCIPAL_INVESTIGATOR)
The Eye Centers of Racine and Kenosha, LTDKenoshaWisconsin53142
Pam Lightfield
[email protected]
262-898-5677
Inder Paul Singh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Center for Excellence in Eye Care· Miami, FLVance Thompson Vision· Alexandria, MNEye Care Specialists· Kingston, PAVance Thompson Vision· Sioux Falls, SDThe Eye Centers of Racine and Kenosha, LTD· Kenosha, WI

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