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This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure.
Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment.
Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented.
Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renuvion APR System Treatment | Experimental | Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR Handpiece | Device | The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Contraction From Baseline to Day 365 | Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction. | Baseline, Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| IPR Review | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Nichols | Investigator | Principal Investigator |
| Dan Albershardt | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Plastic Surgery | Olympia | Washington | 98501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renuvion APR System Treatment | Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renuvion APR System Treatment | Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. |
| 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 | Analysis of Contraction From Baseline to Day 365 | Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction. | During this initial study treatment, the investigators realized the importance of fully expressing the helium from the tissue prior to taking the intra-operative measurements as residual helium expands the subcutaneous tissue, resulting in inaccurate contraction measurements. Due to this discovery and the subsequent change in treatment technique for the remaining subjects, the data for subject 001-BBJ is excluded from the intra-operative data tables and analysis. | Posted | Mean | Standard Deviation | percentage of contraction | Baseline, Day 365 |
|
365 Days
An expected treatment effect was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
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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 | Renuvion APR System Treatment | Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Surgical and medical procedures | Non-systematic Assessment | These minor seromas were only visible by ultrasound and would have typically gone un-reported had it not been for the ultrasound component of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Nichols, MD | Pearl Plastic Surgery | 360-878-9300 | cnichols@pearlplasticsurgery.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 | May 23, 2023 | Nov 13, 2024 | 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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|
| Day 365 |
| Physician Global Aesthetic Improvement | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area. | Day 60, Day 90, Day 180, Day 270, Day 365 |
| Subject Global Aesthetic Improvement | The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area. | Day 60, Day 90, Day 180, Day 270, Day 365 |
| Patient Satisfaction | The subject will complete a Patient Satisfaction Questionnaire (PSQ) | Day 180, Day 270, Day 365 |
| Energy Delivered | Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2) | Day 0 |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m2 |
|
Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. |
|
|
| Secondary | IPR Review | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers. | Posted | Number | Correctly identified sets of images | Day 365 | Sets of images analyzed | Sets of images analyzed |
|
|
|
| Secondary | Physician Global Aesthetic Improvement | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area. | One subject missed the D90 visit. | Posted | Count of Participants | Participants | Day 60, Day 90, Day 180, Day 270, Day 365 |
|
|
|
| Secondary | Subject Global Aesthetic Improvement | The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area. | One subject missed the D90 visit. | Posted | Count of Participants | Participants | Day 60, Day 90, Day 180, Day 270, Day 365 |
|
|
|
| Secondary | Patient Satisfaction | The subject will complete a Patient Satisfaction Questionnaire (PSQ) | Posted | Count of Participants | Participants | Day 180, Day 270, Day 365 |
|
|
|
| Secondary | Energy Delivered | Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2) | Posted | Mean | Standard Deviation | kJ/cm2 | Day 0 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
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| Subcutaneous Nodule | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypoesthesia/numbness (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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The data produced by this sponsored study is the sole property of Sponsor. Sponsor must be provided with the opportunity to review all Investigator-prepared abstracts, publications, or presentations for a period of thirty (30) days for presentational materials and abstracts and forty-five (45) days for manuscripts.
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| Improved, Much Improved, Very Much Improved |
|
| Day 90 |
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| Day 180 |
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| Day 270 |
|
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| Day 365 |
|
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| Improved, Much Improved, Very Much Improved |
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| Day 90 |
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| Day 180 |
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| Day 270 |
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| Day 365 |
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| Improvement Noticed: Improvement in wrinkles |
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| Improvement Noticed: Less sagging skin |
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| Improvement Noticed: Smoother skin texture |
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