Recruiting

Observational Study

Sponsor:

Osheru Inc.

Code:

NCT07144761

Conditions

Blepharoplasty

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Ziplyft

Study Details

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.

Conditions

Blepharoplasty

Study ID

NCT07144761

Start date

Aug, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ziplyft Device

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

Interventions

Ziplyft

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

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 ]
  • Surgeon Satisfaction and Efficiency [ Time Frame: From enrollment to the last visit at 3 months. ]
  • Improvement in Eye Age [ Time Frame: From enrollment to the last visit at 3 months. ]
  • Measure the success of tissue adhesive for wound closure. [ Time Frame: From enrollment to the last visit at 3 months. ]
  • Post-operative ecchymosis [ Time Frame: From enrollment to the last visit at 3 months. ]
  • Eyelid Symmetry [ Time Frame: From enrollment to the last visit at 3 months. ]
  • Improved case time [ Time Frame: From enrollment to last visit at 3 months. ]

Central Contacts and Locations

Central contacts

Locations

Center for Excellence in Eye Care

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Ana C Victoria, MD

Vance Thompson Vision

Recruiting

Alexandria, Minnesota, United States, 56308

Contacts

Principal Investigator:

Deborah Ristvedt, DO

Eye Care Specialists

Recruiting

Kingston, Pennsylvania, United States, 18704

Contacts

Principal Investigator:

Richard Roth, MD

Vance Thompson Vision

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Principal Investigator:

Zachary Keenum, MD

The Eye Centers of Racine and Kenosha, LTD

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Principal Investigator:

Inder Paul Singh, MD

More Information

Sponsor

Osheru Inc.

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Osheru Inc. on 2025-08-27.