Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
ConditionBlepharoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorOsheru Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Ziplyft
DeviceZiplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Ziplyft DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to the last visit at 3 months2
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.
Time frame
From enrollment to the last visit at 3 months.3
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
Time frame
From enrollment to the last visit at 3 months.4
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.
Time frame
From enrollment to the last visit at 3 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov