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CompletedNCT05590039Updated Aug 20, 2024Results posted

Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

An interventional study of MyEllevate Procedure in Soft Tissue Approximation, Elevation of Subdermis and Elevation of Underlying Muscle, sponsored by Cynosure, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum \& jawline.

Read the detailed description

Subjects are to be enrolled in this clinical study if they are a healthy male or female between the age of 18 - 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a screening/pre-procedure visit which may be performed on the same day as the procedure visit but no more than 30 days prior to their procedure.

02

Conditions studied

  • Soft Tissue Approximation
  • Elevation of Subdermis
  • Elevation of Underlying Muscle
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A healthy male or female between the age of 18 - 65.
  • Must have any or all the following: visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck.
  • Reads and understands English.
  • Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
  • Understands and accepts the obligation and is logistically able to be present for all visits.
  • Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion criteria

Exclusion Criteria:

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.

  • Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
  • Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment.
  • Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.
  • Have an active localized or systemic infection.
  • Have an open wound in area being treated.
  • Have a significant systemic illness or an illness localized in area being treated.
  • Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck).
  • Have a history of thrombophlebitis.
  • Have a history of heart failure or kidney disease.
  • Have a history of allergic reaction or intolerance to the anesthesia used during the procedure.
  • Have a history of poor wound healing.
  • Have a history of poor circulation.
  • Have a systemic autoimmune disease known to impair wound healing.
  • Have a history of keloid formation.
  • Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
  • Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment for MyEllevate Procedure

    The subjects were treated with the MyEllevate procedure.

    Device: MyEllevate Procedure

Interventions

  • DeviceMyEllevate Procedure

    The defined study area will be identified and may be marked with a surgical marker. A local tumescent anesthetic, such as lidocaine, will be injected to the area prior to the procedure. The MyEllevate® device will be used in accordance with the Instructions for Use (IFU) manual for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum and jawline.

05

What researchers measure

Primary outcomes

  1. Physician Global Aesthetic Improvement Score (PGAIS)

    The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened.

    Time frame: 30 days post last treatment

06

Results

Posted Aug 20, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment for MyEllevate Procedure
Started10
Completed10
Not completed0

Outcome measures

PrimaryPhysician Global Aesthetic Improvement Score (PGAIS)

The physician will grade the improvement that they see at the 30 day follow up (30 days post treatment). They will grade them as one of the following: Very Much Improved, Much Improved, Improved, No Change, or Worsened.

Time frame:
30 days post last treatment
Reported as:
Count of participants · Participants
Physician Global Aesthetic Improvement Score (PGAIS)
ParticipantsTreatment for MyEllevate Procedure
Very Much Improved5
Much Improved3
Improved2
No Change0
Worsened0

Adverse events

Collected over Adverse events were collected until 90 days post treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment for MyEllevate Procedure0/10 (0%)0/10 (0%)4/10 (40%)
Most frequent other events
Most frequent other events
EventTreatment for MyEllevate Procedure
BruisingSkin and subcutaneous tissue disorders3/10
EdemaSkin and subcutaneous tissue disorders1/10
RashSkin and subcutaneous tissue disorders1/10
Pain/tendernessSkin and subcutaneous tissue disorders1/10
Skin discolorationSkin and subcutaneous tissue disorders1/10
Skin redundancySkin and subcutaneous tissue disorders1/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment for MyEllevate Procedure
<=18 years0
Between 18 and 65 years10
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Treatment for MyEllevate Procedure
Female10
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Treatment for MyEllevate Procedure
Fitzpatrick Skin Types
Fitzpatrick Skin Types(Participants)Treatment for MyEllevate Procedure
Fitzpatrick Skin Type I1
Fitzpatrick Skin Type II2
Fitzpatrick Skin Type III5
Fitzpatrick Skin Type IV2
Fitzpatrick Skin Type V0
Fitzpatrick Skin Type VI0
07

Study locations

2 sites
  • New Jersey Plastic Surgery
    Montclair, New Jersey 07042, United States
  • Aesthetic Pavilion Ambulatory Surgery Center
    Staten Island, New York 10306, United States
08

References and documents

Publications

  • Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. PubMed 31896400 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 14, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05590039
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Oct 21, 2022
Start date
Jul 8, 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Results posted
Aug 20, 2024
Last update
Aug 20, 2024

Study contacts

David Canavan
study director · Cynosure, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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