RecruitingNot Applicable

Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

United States200 participantsStarted 2025-08

Plain-language 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.

Who can participate

Age range35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide signed written consent prior to participation in any study-related procedures.
✓. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
✓. Male or female adults, ≥ 35 years old at the Preoperative Visit
✓. Willing to return for required follow-up visits.
✓. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
✓. 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

✕. Subjects with a current Ptosis diagnosis
✕. Subjects with a history of Graves' Disease
✕. Subjects with Myasthenia Gravis
✕. 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).
✕. Subjects that have had any previous surgery eyelid or eyebrow region.
✕. 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.
✕. Active or recent (within 3 months) tobacco user
✕. Allergy to adhesive glue

What they're measuring

Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes

Timeframe: From enrollment to the last visit at 3 months

Surgeon Satisfaction and Efficiency

Timeframe: From enrollment to the last visit at 3 months.

Improvement in Eye Age

Timeframe: From enrollment to the last visit at 3 months.

Measure the success of tissue adhesive for wound closure.

Timeframe: From enrollment to the last visit at 3 months.

Post-operative ecchymosis

Timeframe: From enrollment to the last visit at 3 months.

Eyelid Symmetry

Timeframe: From enrollment to the last visit at 3 months.

Improved case time

Timeframe: From enrollment to last visit at 3 months.

Trial details

NCT IDNCT07144761

SponsorOsheru Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Patricia Buehler, MD

541-419-4412 pbuehler@osheru.com

View on ClinicalTrials.gov More Blepharoplasty trials

Who can participate

Age range35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide signed written consent prior to participation in any study-related procedures.
✓. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
✓. Male or female adults, ≥ 35 years old at the Preoperative Visit
✓. Willing to return for required follow-up visits.
✓. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
✓. 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

✕. Subjects with a current Ptosis diagnosis
✕. Subjects with a history of Graves' Disease
✕. Subjects with Myasthenia Gravis
✕. 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).
✕. Subjects that have had any previous surgery eyelid or eyebrow region.
✕. 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.
✕. Active or recent (within 3 months) tobacco user
✕. Allergy to adhesive glue

What they're measuring

Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes

Timeframe: From enrollment to the last visit at 3 months

Surgeon Satisfaction and Efficiency

Timeframe: From enrollment to the last visit at 3 months.

Improvement in Eye Age

Timeframe: From enrollment to the last visit at 3 months.

Measure the success of tissue adhesive for wound closure.

Timeframe: From enrollment to the last visit at 3 months.

Post-operative ecchymosis

Timeframe: From enrollment to the last visit at 3 months.

Eyelid Symmetry

Timeframe: From enrollment to the last visit at 3 months.

Improved case time

Timeframe: From enrollment to last visit at 3 months.