BlepharoplastyNCT07144761
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
A study testing Ziplyft in people with Blepharoplasty, run by Osheru Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Blepharoplasty
- What is being tested?
- Ziplyft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Active or recent (within 3 months) tobacco user
- Allergy to adhesive glue
- 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.
- Pregnant or nursing females.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Vance Thompson Vision
Alexandria, Minnesota, 56308
Tiffany Facile, MBA, 605-254-7126, tiffany.facile@vancethompsonvision.com
Deborah Ristvedt, DO
- Recruiting
The Eye Centers of Racine and Kenosha, LTD
Kenosha, Wisconsin, 53142
Pam Lightfield, 262-898-5677, plightfield@amazingeye.com
Inder Paul Singh, MD
- Recruiting
Eye Care Specialists
Kingston, Pennsylvania, 18704
Patti Meyers, 570-714-5910, patti.myers@vipeyes.com
Richard Roth, MD
- Recruiting
Center for Excellence in Eye Care
Miami, Florida, 33176
Elizabeth Vargas, 305-598-2020, study2@centerforeyecare.com
Ana C Victoria, MD
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Tiffany Facile, MBA, 605-254-7126, tiffany.facile@vancethompsonvision.com
Zachary Keenum, MD
About this study
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
- Being tested
- Ziplyft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiplyftDevice
Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.
| Study group | Role | What they receive |
|---|---|---|
| Ziplyft Device | Experimental | Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. Receives: Device: Ziplyft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes
Demonstrate an improvement in overall patient satisfaction by comparing pre-operative and post-operative patient reported outcome scores.
FACE-Q - Aesthetics - Appearance - Satisfaction with facial appearance FACE-Q - Aesthetics - Appearance - Satisfaction with Eyes
On a scale of 1-4 Very Dissatisfied being 1 and Very Satisfied being 4
Measured: From enrollment to the last visit at 3 months
Surgeon Satisfaction and Efficiency
Demonstrate surgeon satisfaction and efficiency with Ziplyft™, measured by Surgeon Satisfaction Survey with questions focused on ease of procedure, patient tolerance, device useability, surgical technique, procedural time, wound closure, need for suture, ease of achieving symmetry, device placement on the lid crease, cutting mechanism, seal of the zipper-locked tissue, surgical time and evaluating for post-operative complications with 5 being better outcome and 1 being worse.
Measured: From enrollment to the last visit at 3 months.
Improvement in Eye Age
Demonstrate improvement in Eye Age and Face Age after the Ziplyft™ procedure.
FACE-Q - Aesthetics - Appearance - Aging Appraisal On a scale of 1-4, with 1 being Definitely Disagree and 4 being Definitely agree
Measured: From enrollment to the last visit at 3 months.
Measure the success of tissue adhesive for wound closure.
Measuring the success of the tissue adhesive involves evaluating the following: Visual inspection, Adhesion strength and adherence, and Patient satisfaction. Questions added in the patient satisfaction survey about comfort of glue, ease of blinking, aesthetically acceptable with 1 being a worse outcome and 4 being better.
Measured: From enrollment to the last visit at 3 months.
Post-operative ecchymosis
Document post-operative ecchymosis with Ziplyft. Measured by post-operative photographs.
Measured: From enrollment to the last visit at 3 months.
Eyelid Symmetry
To achieve optimal eyelid symmetry after eyelid surgery with Ziplyft™ by independent reviewers' assessments.
Measurement of symmetry will be judged on a scale of 1-4 by an independent reviewer based on post-op patient photos. 1 being worse and 4 being better outcome.
Measured: From enrollment to the last visit at 3 months.
Improved case time
Demonstrate improved case time with Ziplyft™
Measured: From enrollment to last visit at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osheru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144761
- Sponsor's protocol ID
- 6520-Osheru
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
- ClinicalTrials.gov ID
- NCT07144761
- Acronym / sponsor ID
- 6520-Osheru
- Conditions
- Blepharoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osheru Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ziplyft Device | Experimental | Device: ZiplyftZiplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiplyftZiplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™. | Device | Ziplyft Device |
Primary outcome
Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes
Time frame: From enrollment to the last visit at 3 months
Demonstrate an improvement in overall patient satisfaction by comparing pre-operative and post-operative patient reported outcome scores. FACE-Q - Aesthetics - Appearance - Satisfaction with facial appearance FACE-Q - Aesthetics - Appearance - Satisfaction with Eyes On a scale of 1-4 Very Dissatisfied being 1 and Very Satisfied being 4
Surgeon Satisfaction and Efficiency
Time frame: From enrollment to the last visit at 3 months.
Demonstrate surgeon satisfaction and efficiency with Ziplyft™, measured by Surgeon Satisfaction Survey with questions focused on ease of procedure, patient tolerance, device useability, surgical technique, procedural time, wound closure, need for suture, ease of achieving symmetry, device placement on the lid crease, cutting mechanism, seal of the zipper-locked tissue, surgical time and evaluating for post-operative complications with 5 being better outcome and 1 being worse.
Improvement in Eye Age
Time frame: From enrollment to the last visit at 3 months.
Demonstrate improvement in Eye Age and Face Age after the Ziplyft™ procedure. FACE-Q - Aesthetics - Appearance - Aging Appraisal On a scale of 1-4, with 1 being Definitely Disagree and 4 being Definitely agree
Measure the success of tissue adhesive for wound closure.
Time frame: From enrollment to the last visit at 3 months.
Measuring the success of the tissue adhesive involves evaluating the following: Visual inspection, Adhesion strength and adherence, and Patient satisfaction. Questions added in the patient satisfaction survey about comfort of glue, ease of blinking, aesthetically acceptable with 1 being a worse outcome and 4 being better.
Post-operative ecchymosis
Time frame: From enrollment to the last visit at 3 months.
Document post-operative ecchymosis with Ziplyft. Measured by post-operative photographs.
Eyelid Symmetry
Time frame: From enrollment to the last visit at 3 months.
To achieve optimal eyelid symmetry after eyelid surgery with Ziplyft™ by independent reviewers' assessments. Measurement of symmetry will be judged on a scale of 1-4 by an independent reviewer based on post-op patient photos. 1 being worse and 4 being better outcome.
Improved case time
Time frame: From enrollment to last visit at 3 months.
Demonstrate improved case time with Ziplyft™
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Blepharoplasty
Not yet recruiting
Enhancing the Durability of Thread-Assisted Brow Suspension Through Upper Blepharoplasty-Assisted Ligament Release
Brow Ptosis, Dermatochalasis
Not yet recruitingPhase 2
The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial
Lower Eyelid Bags
Not yet recruitingPhase 3
Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes
Dermatochalasis of Upper Eyelid, Blepharoplasty
RecruitingPhase 4
The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty
Scar Formation
Recruiting
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Dermatochalasis of Upper Eyelid, Ptosis, Eyelid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ziplyft in people with Blepharoplasty, run by Osheru Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Buehler, MD (541-419-4412, pbuehler@osheru.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.