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This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.
This is a prospective, single-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotational fractional resection (1.5mm Diameter Device) | Experimental | Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational fractional resection (1.5mm Diameter Device) | Device | Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale | Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | 90 days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied"). | 90 days post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin McIntosh | Recros Medica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steve Yoelin, MD Medical Associates, Inc. | Newport Beach | California | 92663 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale | Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | Number of participants with at least a one grade improvement on the Submental Skin Laxity Scale | Posted | Count of Participants | Participants | 90 days post treatment |
|
|
90 days post treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotational Fractional Resection (1.5mm Diameter Device) | Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin irritation near procedure area as a result of a silicone pad |
This study evaluated 1.5mm diameter skin resections, the first-generation prototype, in the submental area.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Recros Medica | 925-223-8581 | clinical@recrosmedica.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2019 | Jan 15, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale |
Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) |
| 90 days post treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Submental Skin Laxity Scale score | Measurement of submental skin laxity on a 5 point scale: grades 0-4. Subjects were enrolled with moderate or severe submental skin laxity. | Count of Participants | Participants |
|
| Participants |
|
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| Secondary | Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied"). | Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline | Posted | Count of Participants | Participants | 90 days post treatment |
|
|
|
| Secondary | Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale | Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) | 1 grade improvement (Mild to None) | Posted | Count of Participants | Participants | 90 days post treatment |
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| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012875 | Skin Diseases, Metabolic |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |