Trial Outcomes & Findings for Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure (NCT NCT05590039)
NCT ID: NCT05590039
Last Updated: 2024-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
30 days post last treatment
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Treatment for MyEllevate Procedure
The subjects were treated with the MyEllevate procedure.
MyEllevate 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.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment for MyEllevate Procedure
n=10 Participants
The subjects were treated with the MyEllevate procedure.
MyEllevate 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=10 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=10 Participants
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Age, Categorical
>=65 years
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0 Participants
n=10 Participants
|
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Sex: Female, Male
Female
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10 Participants
n=10 Participants
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Sex: Female, Male
Male
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0 Participants
n=10 Participants
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Fitzpatrick Skin Types
Fitzpatrick Skin Type I
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1 Participants
n=10 Participants
|
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Fitzpatrick Skin Types
Fitzpatrick Skin Type II
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2 Participants
n=10 Participants
|
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Fitzpatrick Skin Types
Fitzpatrick Skin Type III
|
5 Participants
n=10 Participants
|
|
Fitzpatrick Skin Types
Fitzpatrick Skin Type IV
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2 Participants
n=10 Participants
|
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Fitzpatrick Skin Types
Fitzpatrick Skin Type V
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0 Participants
n=10 Participants
|
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Fitzpatrick Skin Types
Fitzpatrick Skin Type VI
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0 Participants
n=10 Participants
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PRIMARY outcome
Timeframe: 30 days post last treatmentThe 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.
Outcome measures
| Measure |
Treatment for MyEllevate Procedure
n=10 Participants
The subjects were treated with the MyEllevate procedure.
MyEllevate 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.
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|---|---|
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Physician Global Aesthetic Improvement Score (PGAIS)
Very Much Improved
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5 Participants
|
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Physician Global Aesthetic Improvement Score (PGAIS)
Much Improved
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3 Participants
|
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Physician Global Aesthetic Improvement Score (PGAIS)
Improved
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2 Participants
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Physician Global Aesthetic Improvement Score (PGAIS)
No Change
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0 Participants
|
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Physician Global Aesthetic Improvement Score (PGAIS)
Worsened
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0 Participants
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Adverse Events
Treatment for MyEllevate Procedure
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment for MyEllevate Procedure
n=10 participants at risk
The subjects were treated with the MyEllevate procedure.
MyEllevate 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.
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|---|---|
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Skin and subcutaneous tissue disorders
Bruising
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30.0%
3/10 • Adverse events were collected until 90 days post treatment.
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Skin and subcutaneous tissue disorders
Edema
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10.0%
1/10 • Adverse events were collected until 90 days post treatment.
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Skin and subcutaneous tissue disorders
Rash
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10.0%
1/10 • Adverse events were collected until 90 days post treatment.
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Skin and subcutaneous tissue disorders
Pain/tenderness
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10.0%
1/10 • Adverse events were collected until 90 days post treatment.
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Skin and subcutaneous tissue disorders
Skin discoloration
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10.0%
1/10 • Adverse events were collected until 90 days post treatment.
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Skin and subcutaneous tissue disorders
Skin redundancy
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10.0%
1/10 • Adverse events were collected until 90 days post treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER