THE LIFT STUDY
(Evaluation of Patient and Physician Satisfaction with the Zift eLevatIon of Facial Tissue Clinical Study)
Principal Investigator: Dr. Peter Hilger
Clinicaltrials.gov identifier: NCT03055819,1068-001Rev3
Design: Single-arm, open label study to understand the safety and performance of the ZiftLift device.
The study is an FDA approved IDE study under the Early Feasibility Study (EFS) program to enroll up to 20 patients.
- Elevation of tissue measured using standardized light photography.
- Patient satisfaction, using a standardized questionnaire and three modules of the Face-Q survey, a validated outcome measurement tool.
- Physician satisfaction, using a standardized questionnaire.
Other endpoints including safety and functional data will also be collected.
Data will be collected pre-procedure, during the procedure, and at 7, 30, 60 and 90 days.
Patients participating in long-term follow up will have data collected at 6 months, 1, 2, 3, and 4 years.
Enrollment was complete in February 2018.
CADAVER & BENCH STUDIES
The Zift implant has been studied in both acute and long-term (90 day) animal models (pig and sheep) as well as extensive animal and human cadaver studies. Pre-clinical safety has been supported by physical examination, dissection, histology and CT-scan data as well as extensive bench-testing of the implant and delivery system.