RECRUITING

Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Quick Facts

Study Start:2025-08

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07144761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 4. Willing to return for required follow-up visits. 5. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator. 6. 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.	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.

Inclusion Criteria

Exclusion 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
4. Willing to return for required follow-up visits.
5. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
6. 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.

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.

Contacts and Locations

Study Contact

Patricia Buehler, MD

CONTACT

541-419-4412

pbuehler@osheru.com

Becky Weathers

CONTACT

541-312-4622

bweathers@osheru.com

Study Locations (Sites)

Center for Excellence in Eye Care

Miami, Florida, 33176

United States

Vance Thompson Vision

Alexandria, Minnesota, 56308

United States

Eye Care Specialists

Kingston, Pennsylvania, 18704

United States

Vance Thompson Vision

Sioux Falls, South Dakota, 57108

United States

The Eye Centers of Racine and Kenosha, LTD

Kenosha, Wisconsin, 53142

United States

Collaborators and Investigators

Sponsor: Osheru Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-08

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Blepharoplasty