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The study was terminated early due to sponsor decision unrelated to safety or efficacy findings
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The purpose of this clinical study is to determine the effectiveness of the Erchonia® GVS in improving the appearance of skin laxity on the abdominal region.
This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® GVS Laser in improving the appearance of skin laxity on the abdominal region. Participants will receive 8 treatments over the course of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia GVS Laser | Experimental | 405nm violet and 520nm green laser light therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia GVS Laser | Device | 405nm violet and 520nm green laser light therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. | Reviewers will be blinded to post-treatment (12 weeks) vs. baseline untreated area. The order in which images will be presented will be randomized. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as at least 2 of the 3 blinded evaluators correctly identifying a subject's pre-treatment and post-treatment (study endpoint) photographs for 80% or more of subjects. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale- Investigator Assessed | The Investigator-assessed Global Aesthetic Improvement Scale (GAIS) is a validated, subjective qualitative assessment tool used to evaluate overall aesthetic improvement from baseline to post-treatment. The scale ranges from +3 to -1, where +3 = very much improved, +2 = much improved, +1 = improved, 0 = no change, and -1 = worse. Higher scores indicate greater aesthetic improvement. The outcome measure is reported as the mean GAIS score across all analyzed participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cesar A. Lara M.D. Weight Loss & Wellness | Dunedin | Florida | 34698 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia GVS Laser | 405nm violet and 520nm green laser light therapy. Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia GVS Laser | 405nm violet and 520nm green laser light therapy. Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy. |
| 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 | Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators. | Reviewers will be blinded to post-treatment (12 weeks) vs. baseline untreated area. The order in which images will be presented will be randomized. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as at least 2 of the 3 blinded evaluators correctly identifying a subject's pre-treatment and post-treatment (study endpoint) photographs for 80% or more of subjects. | The trial was terminated early before the planned sample size was reached and before the scheduled blinded photographic review was conducted. This primary outcome was to be assessed after all subjects completed 12-week endpoint photos. Because the study ended before this review was initiated, no data were collected or analyzed for this outcome; participants analyzed = 0. | Posted | 12 weeks |
|
12 Weeks
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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 | Erchonia GVS Laser | 405nm violet and 520nm green laser light therapy. Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Erchonia Corp | 8882420571 | tsammons@erchonia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2025 | Feb 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| 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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| 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Erchonia GVS Laser |
405nm violet and 520nm green laser light therapy. Erchonia GVS Laser: 405nm violet and 520nm green laser light therapy. |
|
| Secondary | Global Aesthetic Improvement Scale- Investigator Assessed | The Investigator-assessed Global Aesthetic Improvement Scale (GAIS) is a validated, subjective qualitative assessment tool used to evaluate overall aesthetic improvement from baseline to post-treatment. The scale ranges from +3 to -1, where +3 = very much improved, +2 = much improved, +1 = improved, 0 = no change, and -1 = worse. Higher scores indicate greater aesthetic improvement. The outcome measure is reported as the mean GAIS score across all analyzed participants. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |