Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04902599
Status:
TERMINATED
Last Update Posted:
2022-09-22
First Post:
2021-04-28
Brief Title:
RenuvionJ-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms Dissection Technique Comparison
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
RenuvionJ-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms a Randomized Intra-patient Left-right Arm Non-inferiority Clinical Trial Comparing Vaser to Blunt Dissection for Site Preparation
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dr Smart is leaving the instution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The RenuvionJ-plasma cold atmospheric plasma device has been in clinical use in aesthetics since its approval by the FDA in 2012 but no rigorous clinical trials have been published to quantify the effect of the skin tightening in any body area In current clinical practice the device is frequently used in conjunction with liposuction and both blunt and ultrasound assisted dissection cannulas are utilized There is some thought that ultrasound assisted dissection may impart some tissue warming and skin tightening effects but these effects are anecdotal at this time and not rigorously scientifically tested Our study is designed to address these practice gaps by quantifying the improvement in skin laxity by objective measurements and comparing results obtained between blunt and ultrasound assisted dissection techniques without concurrent liposuction
This study will use a single-blind prospective right-left sided comparator design to assess the effect of the RenuvionJ-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design This study will be a prospective single-blind assessor randomized right-left sided non-inferiority clinical trial
Procedures
This is a randomized right-left arm single blinded prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the RenuvionJ-plasma cold atmospheric plasma CAP device while quantitatively evaluating the efficacy of the Renuvion device
A total of 15 patients will be enrolled Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the RenuvionJ-Plasma procedure
This study will use a single-blind prospective right-left sided comparator design to assess the effect of the RenuvionJ-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design This study will be a prospective single-blind assessor randomized right-left sided non-inferiority clinical trial
Procedures
This is a randomized right-left arm single blinded prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the RenuvionJ-plasma cold atmospheric plasma CAP device while quantitatively evaluating the efficacy of the Renuvion device
A total of 15 patients will be enrolled Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the RenuvionJ-Plasma procedure
Detailed Description:
The RenuvionJ-plasma cold atmospheric plasma device has been in clinical use in aesthetics since its approval by the FDA in 2012 but no rigorous clinical trials have been published to quantify the effect of the skin tightening in any body area In current clinical practice the device is frequently used in conjunction with liposuction and both blunt and ultrasound assisted dissection cannulas are utilized There is some thought that ultrasound assisted dissection may impart some tissue warming and skin tightening effects but these effects are anecdotal at this time and not rigorously scientifically tested Our study is designed to address these practice gaps by quantifying the improvement in skin laxity by objective measurements and comparing results obtained between blunt and ultrasound assisted dissection techniques without concurrent liposuction
Study Design
This study will use a single-blind prospective right-left sided comparator design to assess the effect of the RenuvionJ-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design This study will be a prospective single-blind assessor randomized right-left sided non-inferiority clinical trial
Bliniding
To blind the study the sub-investigatoroperator will use an internet-based random number generator to assign the right arm to blunt dissection odd numbers or ultrasound-assisted dissection zero and even numbers Due to the nature of the procedure it will be impossible to blind the operator and the patient to site preparation technique The assessors and coordinators will remain blinded to the treatment assignment throughout the study Measurements and photographs will not be labeled regarding which site preparation method was used A patient specific paper chart will have treatment assignments which will minimize the potential for inadvertent unblinding and allow for unblinding in the event unblinding becomes necessary
Study Purposes and Objectives
1 Quantify the clinical improvement from baseline to 1 3 and 9 months after treatment of underarm laxity using the RenuvionJ-Plasma cold atmospheric plasma CAP device with both Vaser ultrasound-assisted dissection and blunt dissection methods for site preparation in a randomized right-left arm single blinded prospective clinical trial
1 Compare ultrasound-assisted site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in area between overlaid photographs taken in both sagittal and coronal planes
2 Compare ultrasound-assisted site prepared side baseline photographs to 1-month 3-month and 9 month post-treatment photos to assess change in distance of lowest hanging point between overlaid photographs taken in both sagittal and coronal planes
3 Compare ultrasound-assisted site prepared side linear circumference at baseline to 1-month 3-month and 9-month post-treatment measurements to assess change in linear circumference of treated area
4 Compare blunt dissection site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in area between overlaid photographs taken in both sagittal and coronal planes
5 Compare blunt dissection site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in distance of lowest hanging point between overlaid photographs taken in both sagittal and coronal planes
6 Compare blunt dissection site prepared side linear circumference at baseline to 1-month 3-month and 9-month post-treatment measurements to assess change in linear circumference of treated area
2 Compare non-inferiority of clinical endpoints between blunt dissection cannula and Vaser ultrasound-assisted cannula for site preparation of RenuvionJ-Plasma treatment at 1 3 and 9 months post treatment
1 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in area change in sagittal and coronal planes as determined in objective 1 between the two treatment modalities
2 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in lowest hanging point change in sagittal and coronal planes as determined in objective 1 between the two treatment modalities
3 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in linear circumference of treated area change as determined in objective 1 between the two treatment modalities
3 Assess patient reported outcomes of the treatment using the BODY-Q and Skindex-16 instruments
Procedures
This is a randomized right-left arm single blinded prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the RenuvionJ-plasma cold atmospheric plasma CAP device while quantitatively evaluating the efficacy of the Renuvion device
A total of 15 patients will be enrolled Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the RenuvionJ-Plasma procedure The study timeline is summarized in table 1
Screening
For screening subjects with qualifying underarm skin laxity without excess fat will be asked to read and sign the informed consent document They will be reminded that they are to take their time and if necessary take it home for further consideration Questions will be answered Those meeting inclusion exclusion criteria who have signed informed consent will be enrolled
After answering questions and prior to the treatment the Principal Investigator PI will examine the upper body of the patient and assess the type of upper arm skin laxity amount of underlying fat and perform measurements to include weight mid-biceps arm circumference and skin ptosis from brachial sulcus to the lowermost border of pendulous skin Standardized photographs of the treatment area will be obtained in sagittal and coronal planes of the arms abducted to 90o with elbows flexed to 90o The patient will complete the Body-Q and Skindex-16 patient reported outcomes measurement tools
Using a random number generator the patient will be randomized to undergo blunt dissection vs ultrasound-assisted dissection of the right arm The left arm will receive the site preparation modality not selected for the right arm The sub-investigator will perform the randomization on the day of the procedure and the PI will be blinded to the treatment assignment
At follow up visits the blinded PI will perform an upper body exam and repeat mid-biceps arm circumference and skin ptosis measurements Standardized photographs will be repeated in sagittal and coronal planes as at baseline The patient will complete the Body-Q and Skindex-16 patient reported outcomes measurement tools Treatment related adverse event information will be collected
Adverse events
Evaluations for adverse events will be carried out by the PI or sub-I at scheduled follow up visits or if the clinic is notified of problems by the patient If adverse events have not resolved at the time of the final visit the patient will be followed for resolution of these events by phone or office visits Specific adverse events to be tracked will include pain bleeding hematoma formation infection nerve damage scarring and skin discoloration in the treatment sites Major cardiac and neurologic events will also be noted but are not anticipated based on existing data on these and similar procedures
Procedure
The patient will arrive on the day of the procedure and sites will be prepped in a standard sterile fashion Patients will receive diazepam and midazolam orally as appropriate for anxiolysis or mild sedation Local anesthesia will be administered using tumescent lidocaine 1 g lidocaine and 1 mg epinephrine in 100 ml plus 10 mEq sodium bicarbonate in 10 ml added to 1000 ml of 09 physiologic saline at a maximum dose of 28 mgkg to prevent toxicity 4 mm incisions will be made at the distal portion of the posterior upper arm approximately 25-4 cm from the olecranon process when the arm is at 90 degrees of flexion and at the most proximal portion of the posterior upper arm in the axillary crease A standard 3 mm blunt liposuction cannula not attached to suction will be used to dissect the subcutaneous tissue of the posterior upper arm on the side randomized to blunt dissection Several passes will be made using the blunt dissection cannula with increasingdecreasing sizes until the dissection plane has been completed The RenuvionJ-Plasma CAP device will be inserted into the openings created for the dissection and 4 passes of the device applied to the underside of the dermis will be made at a setting of 80mJ and 20 L of flow This process will be repeated on the contralateral side using the ultrasound assisted device Vaser in place of the blunt dissection cannula at the setting of 60 energy 10W for no greater than 25 min
Post-procedure the cannula wounds will be closed with one 4-0 nylon suture and otherwise left open to allow for drainage and venting The upper arms will be wrapped with absorbent pads and an industry standard upper arm compression garment which we will provide The compression garment is to be worn for 2 weeks following the procedure Post-operative pain will be managed with acetaminophen and 5mg325mg hydrocodoneacetaminophen as needed The patient will shower normally the following day and expect some mild serosanginous drainage from the incision sites over 48 hours following the procedure After 48 hours the patient will then begin daily placement of a thin layer of white petrolatum over the incision sites followed by a small bandage or Band-aid
Evaluations
Efficacy evaluations will be performed at baseline 1-month post-procedure 3-months post-procedure and 9-months post-procedure For each evaluation a coordinator who is blinded to the treatment assignment will measure upper arm circumference of each arm at the point of maximum diameter and vertical distance from the brachial sulcus to the lowermost border of pendulous skin when the arms are positioned at 90o abducted at the shoulder and 90o flexed at the elbow Circumference will be measured with a flexible measuring tape and vertical distance will be measured using a rigid ruler These measurements will be entered into a spreadsheet Microsoft Excel Microsoft Corporation Redmond WA and analyzed using R statistical software R Foundation for Statistical Computing Vienna Austria to determine the mean change from baseline and standard deviation at 1 3 and 9-months post-procedure and between 1- and 3-months post-procedure 1- and 9- months post-procedure and 3- and 9-months post-procedure T-testing will be performed using the R statistical software package to compare before and after measurements at each time point from baseline and between each follow up interval P-values will be calculated with a significance level of P 005 being considered significant
Standardized photographs of the treatment area will be obtained by trained staff photographers in sagittal and coronal planes of the arms abducted to 90o with elbows flexed to 90o Digital photographs will be obtained at baseline 1-month post-procedure 3-months post-procedure and 9-months post-procedure Photographs will be obtained using a Canon camera for sagittal coronal and oblique views and Visia system Canfield Scientific Inc Parsippany NJ for sagittal and oblique views
The patient will complete the clinically validated Body-Q patient reported outcomes measurement tool for upper arms at baseline 1 3 and 9-months post-procedure A copy of this assessment tool is included in the supporting documents section
1 Primary Efficacy Measures
The efficacy will be measured using the change in area and vertical distance calculated from standardized digital photographic overlays using the sagittal view between baseline and 9-months post-procedure
2 Secondary Efficacy Measures
Unless otherwise stated secondary efficacy measures will be calculated between baseline and 1-month post-procedure baseline and 3-months post-procedure baseline and 9-months post-procedure between 1- and 3-months post-procedure between 1- and 9-months post-procedure and between 3- and 9-months post-procedure These measures will include the change in area and vertical distance calculated from standardized digital photographic overlays using the sagittal view for non-primary endpoint time intervals the change in area and vertical distance calculated from standardized digital photographic overlays using the coronal view the difference in arm circumference the difference in measured vertical pendulous skin and differences in Body-Q and Skindex-16 patient recorded outcomes measurements and subjective blinded assessor assessments
3 Adverse events
Adverse events will be catalogued detailed and presented in table format
Study Design
This study will use a single-blind prospective right-left sided comparator design to assess the effect of the RenuvionJ-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design This study will be a prospective single-blind assessor randomized right-left sided non-inferiority clinical trial
Bliniding
To blind the study the sub-investigatoroperator will use an internet-based random number generator to assign the right arm to blunt dissection odd numbers or ultrasound-assisted dissection zero and even numbers Due to the nature of the procedure it will be impossible to blind the operator and the patient to site preparation technique The assessors and coordinators will remain blinded to the treatment assignment throughout the study Measurements and photographs will not be labeled regarding which site preparation method was used A patient specific paper chart will have treatment assignments which will minimize the potential for inadvertent unblinding and allow for unblinding in the event unblinding becomes necessary
Study Purposes and Objectives
1 Quantify the clinical improvement from baseline to 1 3 and 9 months after treatment of underarm laxity using the RenuvionJ-Plasma cold atmospheric plasma CAP device with both Vaser ultrasound-assisted dissection and blunt dissection methods for site preparation in a randomized right-left arm single blinded prospective clinical trial
1 Compare ultrasound-assisted site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in area between overlaid photographs taken in both sagittal and coronal planes
2 Compare ultrasound-assisted site prepared side baseline photographs to 1-month 3-month and 9 month post-treatment photos to assess change in distance of lowest hanging point between overlaid photographs taken in both sagittal and coronal planes
3 Compare ultrasound-assisted site prepared side linear circumference at baseline to 1-month 3-month and 9-month post-treatment measurements to assess change in linear circumference of treated area
4 Compare blunt dissection site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in area between overlaid photographs taken in both sagittal and coronal planes
5 Compare blunt dissection site prepared side baseline photographs to 1-month 3-month and 9-month post-treatment photos to assess change in distance of lowest hanging point between overlaid photographs taken in both sagittal and coronal planes
6 Compare blunt dissection site prepared side linear circumference at baseline to 1-month 3-month and 9-month post-treatment measurements to assess change in linear circumference of treated area
2 Compare non-inferiority of clinical endpoints between blunt dissection cannula and Vaser ultrasound-assisted cannula for site preparation of RenuvionJ-Plasma treatment at 1 3 and 9 months post treatment
1 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in area change in sagittal and coronal planes as determined in objective 1 between the two treatment modalities
2 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in lowest hanging point change in sagittal and coronal planes as determined in objective 1 between the two treatment modalities
3 Compare ultrasound-assisted site prepared side to blunt dissection prepared side by calculating the difference in linear circumference of treated area change as determined in objective 1 between the two treatment modalities
3 Assess patient reported outcomes of the treatment using the BODY-Q and Skindex-16 instruments
Procedures
This is a randomized right-left arm single blinded prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the RenuvionJ-plasma cold atmospheric plasma CAP device while quantitatively evaluating the efficacy of the Renuvion device
A total of 15 patients will be enrolled Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the RenuvionJ-Plasma procedure The study timeline is summarized in table 1
Screening
For screening subjects with qualifying underarm skin laxity without excess fat will be asked to read and sign the informed consent document They will be reminded that they are to take their time and if necessary take it home for further consideration Questions will be answered Those meeting inclusion exclusion criteria who have signed informed consent will be enrolled
After answering questions and prior to the treatment the Principal Investigator PI will examine the upper body of the patient and assess the type of upper arm skin laxity amount of underlying fat and perform measurements to include weight mid-biceps arm circumference and skin ptosis from brachial sulcus to the lowermost border of pendulous skin Standardized photographs of the treatment area will be obtained in sagittal and coronal planes of the arms abducted to 90o with elbows flexed to 90o The patient will complete the Body-Q and Skindex-16 patient reported outcomes measurement tools
Using a random number generator the patient will be randomized to undergo blunt dissection vs ultrasound-assisted dissection of the right arm The left arm will receive the site preparation modality not selected for the right arm The sub-investigator will perform the randomization on the day of the procedure and the PI will be blinded to the treatment assignment
At follow up visits the blinded PI will perform an upper body exam and repeat mid-biceps arm circumference and skin ptosis measurements Standardized photographs will be repeated in sagittal and coronal planes as at baseline The patient will complete the Body-Q and Skindex-16 patient reported outcomes measurement tools Treatment related adverse event information will be collected
Adverse events
Evaluations for adverse events will be carried out by the PI or sub-I at scheduled follow up visits or if the clinic is notified of problems by the patient If adverse events have not resolved at the time of the final visit the patient will be followed for resolution of these events by phone or office visits Specific adverse events to be tracked will include pain bleeding hematoma formation infection nerve damage scarring and skin discoloration in the treatment sites Major cardiac and neurologic events will also be noted but are not anticipated based on existing data on these and similar procedures
Procedure
The patient will arrive on the day of the procedure and sites will be prepped in a standard sterile fashion Patients will receive diazepam and midazolam orally as appropriate for anxiolysis or mild sedation Local anesthesia will be administered using tumescent lidocaine 1 g lidocaine and 1 mg epinephrine in 100 ml plus 10 mEq sodium bicarbonate in 10 ml added to 1000 ml of 09 physiologic saline at a maximum dose of 28 mgkg to prevent toxicity 4 mm incisions will be made at the distal portion of the posterior upper arm approximately 25-4 cm from the olecranon process when the arm is at 90 degrees of flexion and at the most proximal portion of the posterior upper arm in the axillary crease A standard 3 mm blunt liposuction cannula not attached to suction will be used to dissect the subcutaneous tissue of the posterior upper arm on the side randomized to blunt dissection Several passes will be made using the blunt dissection cannula with increasingdecreasing sizes until the dissection plane has been completed The RenuvionJ-Plasma CAP device will be inserted into the openings created for the dissection and 4 passes of the device applied to the underside of the dermis will be made at a setting of 80mJ and 20 L of flow This process will be repeated on the contralateral side using the ultrasound assisted device Vaser in place of the blunt dissection cannula at the setting of 60 energy 10W for no greater than 25 min
Post-procedure the cannula wounds will be closed with one 4-0 nylon suture and otherwise left open to allow for drainage and venting The upper arms will be wrapped with absorbent pads and an industry standard upper arm compression garment which we will provide The compression garment is to be worn for 2 weeks following the procedure Post-operative pain will be managed with acetaminophen and 5mg325mg hydrocodoneacetaminophen as needed The patient will shower normally the following day and expect some mild serosanginous drainage from the incision sites over 48 hours following the procedure After 48 hours the patient will then begin daily placement of a thin layer of white petrolatum over the incision sites followed by a small bandage or Band-aid
Evaluations
Efficacy evaluations will be performed at baseline 1-month post-procedure 3-months post-procedure and 9-months post-procedure For each evaluation a coordinator who is blinded to the treatment assignment will measure upper arm circumference of each arm at the point of maximum diameter and vertical distance from the brachial sulcus to the lowermost border of pendulous skin when the arms are positioned at 90o abducted at the shoulder and 90o flexed at the elbow Circumference will be measured with a flexible measuring tape and vertical distance will be measured using a rigid ruler These measurements will be entered into a spreadsheet Microsoft Excel Microsoft Corporation Redmond WA and analyzed using R statistical software R Foundation for Statistical Computing Vienna Austria to determine the mean change from baseline and standard deviation at 1 3 and 9-months post-procedure and between 1- and 3-months post-procedure 1- and 9- months post-procedure and 3- and 9-months post-procedure T-testing will be performed using the R statistical software package to compare before and after measurements at each time point from baseline and between each follow up interval P-values will be calculated with a significance level of P 005 being considered significant
Standardized photographs of the treatment area will be obtained by trained staff photographers in sagittal and coronal planes of the arms abducted to 90o with elbows flexed to 90o Digital photographs will be obtained at baseline 1-month post-procedure 3-months post-procedure and 9-months post-procedure Photographs will be obtained using a Canon camera for sagittal coronal and oblique views and Visia system Canfield Scientific Inc Parsippany NJ for sagittal and oblique views
The patient will complete the clinically validated Body-Q patient reported outcomes measurement tool for upper arms at baseline 1 3 and 9-months post-procedure A copy of this assessment tool is included in the supporting documents section
1 Primary Efficacy Measures
The efficacy will be measured using the change in area and vertical distance calculated from standardized digital photographic overlays using the sagittal view between baseline and 9-months post-procedure
2 Secondary Efficacy Measures
Unless otherwise stated secondary efficacy measures will be calculated between baseline and 1-month post-procedure baseline and 3-months post-procedure baseline and 9-months post-procedure between 1- and 3-months post-procedure between 1- and 9-months post-procedure and between 3- and 9-months post-procedure These measures will include the change in area and vertical distance calculated from standardized digital photographic overlays using the sagittal view for non-primary endpoint time intervals the change in area and vertical distance calculated from standardized digital photographic overlays using the coronal view the difference in arm circumference the difference in measured vertical pendulous skin and differences in Body-Q and Skindex-16 patient recorded outcomes measurements and subjective blinded assessor assessments
3 Adverse events
Adverse events will be catalogued detailed and presented in table format
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None