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Poor enrollment
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The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh surgical scars | Experimental | Treatment of scars |
|
| Mature scars | Experimental | Treatment of scars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RevLite (Laser Treatment) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis | The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted. | 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanctuary Medical Aesthetic Center | Boca Raton | Florida | 33431 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fresh Surgical Scars | Device: RevLite (Laser Treatment) |
| FG001 | Mature Scars | Device: RevLite (Laser Treatment) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were no baseline participants who were analyzed that had fresh surgical scars. This study was not completed due to the lack of enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fresh Surgical Scars | Treatment of scars Device: Revlite |
| BG001 | Mature Scars | Treatment of scars Device: Revlite |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis | The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted. | Could not measure accurately with measurement tools. | Posted | 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars) |
|
Adverse Events occurring were captured and followed until the study was terminated, approximately 11 months.
The number of patients at risk is zero because no patients were enrolled in the fresh surgical study arm.
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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 | Fresh Surgical Scars | Treatment of scars Device: Revlite | 0 |
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Early termination leading to small numbers of subjects analyzed.Technical problems with measurement leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure, Inc. | 800-886-2966 | jamie.trimper@cynosure.com |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Mature Scars | Treatment of scars Device: Revlite | 0 | 7 | 0 | 7 | 0 | 7 |
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.