Recruiting

Ziplyft vs. Traditional Surgery

Sponsor:

Osheru Inc.

Code:

NCT07250139

Conditions

Dermatochalasis of Upper Eyelid

Ptosis, Eyelid

Blepharoplasty

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Ziplyft Device

Comparator Arm: Standard Blepharoplasty

Study Details

Brief summary:

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.

Conditions

Dermatochalasis of Upper Eyelid

Ptosis, Eyelid

Blepharoplasty

Study ID

NCT07250139

Start date

Dec 8, 2025

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

May 31, 2026

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 willing to return for required follow-up visits.
4. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
5. 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

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ziplyft 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

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.

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 ]
  • Document post-operative ecchymosis with Ziplyft and standard blepharoplasty [ Time Frame: 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days) ]
  • Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance. [ Time Frame: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation ]
  • Assess patient reported outcomes with Ziplyft versus standard blepharoplasty [ Time Frame: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation ]
  • Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty [ Time Frame: The day of surgery until 2 months (± 1 month) post-operation ]

Central Contacts and Locations

Central contacts

Locations

New Century Ophthalmology

Recruiting

Oxford, North Carolina, United States, 27585

Contacts

Principal Investigator:

Sumeet Jindal, MD

More Information

Sponsor

Osheru Inc.

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • Dermatochalasis of upper eyelid, Ptosis of upper eyelid, blepharoplasty,
  • Ziplyft
  • upper eyelid surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Osheru Inc. on 2025-11-26.