Treatment With the Profound System for Submental Laxity
Public ClinicalTrials.gov record NCT02595216. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Study to Evaluate the Performance of Profound System With Nominal Angle of 75° to the Skin's Surface for Submental Laxity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02595216
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2015
- Primary completion
- Nov 30, 2017
- Completion
- Nov 30, 2017
- Last update posted
- Apr 5, 2017
2015 – 2017
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Premier Plastic Surgery | San Mateo | California | 94401 | — |
| Gladstone Clinic | San Ramon | California | 94583 | — |
| Mark Beaty | Alpharetta | Georgia | 30009 | — |
| Coliseum Health System | Macon | Georgia | 31217 | — |
| Dr. Richard Gentile | Boardman | Ohio | 44512 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02595216, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02595216 live on ClinicalTrials.gov.