Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes [Срок оценки: From enrollment to the last visit at 3 months]
• Surgeon Satisfaction and Efficiency [Срок оценки: From enrollment to the last visit at 3 months.]
• Improvement in Eye Age [Срок оценки: From enrollment to the last visit at 3 months.]
• Measure the success of tissue adhesive for wound closure. [Срок оценки: From enrollment to the last visit at 3 months.]
• Post-operative ecchymosis [Срок оценки: From enrollment to the last visit at 3 months.]
• Eyelid Symmetry [Срок оценки: From enrollment to the last visit at 3 months.]
• Improved case time [Срок оценки: From enrollment to last visit at 3 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Center for Excellence in Eye Care — Miami
• Vance Thompson Vision — Alexandria
• Eye Care Specialists — Kingston
• Vance Thompson Vision — Sioux Falls
• The Eye Centers of Racine and Kenosha, LTD — Kenosha

Идентификаторы

NCT: NCT07144761 · 6520-Osheru

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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