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SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

NCT04969380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-18

No results posted yet for this study

Summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Conditions

  • Skin Laxity

Interventions

DEVICE

Sofwave

The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Sponsors & Collaborators

  • Sofwave Medical LTD

    lead INDUSTRY

Principal Investigators

  • Ruthie Amir, MD · Sofwave

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2023-02-27
Completion
2023-02-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969380 on ClinicalTrials.gov