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Treatment With the Profound System for Submental Laxity

NCT02595216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-06

No results posted yet for this study

Summary

Prospective clinical study to evaluate the Profound efficiency Up to 60 healthy adult volunteers, male or females, 18 to 70 years old. All subjects in this study will receive a single treatment to the submental area with the profound device; subjects will return to four follow- up visits: 1 week post treatment, 1, 3 and 6 months post treatment.

Prior to treatment, tissue will be treated with injected tumescence or local dermal infiltration solution according to the protocol.

Conditions

  • Submental Laxity

Interventions

DEVICE

Profound System

The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity

Sponsors & Collaborators

  • Syneron Medical

    lead INDUSTRY

Principal Investigators

  • Mark Beaty, M.D. · Beaty Facial Plastic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

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 NCT02595216 on ClinicalTrials.gov