Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407791
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-08
Brief Title:
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
Sponsor:
Carilion Clinic
Organization:
Carilion Clinic
Study Overview
Official Title:
Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in the bodys tissues The goal of this research study is to determine the safety and efficacy of a novel proprietary device in the treatment of upper extremity lymphedema This device has been previously studied on healthy people that do not have a diagnosis of lymphedema It was found that using the device on them does not cause significant changes to their vital signs or level of pain Side effects are reported sometimes however these are to be expected and are also frequently reported when people receive the standard of care for their lymphedema Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care Participants will wear this device for approximately 40 minutes and then have certain measurements taken before and after doing so These measurements include the size of their arm how much paindiscomfort they are currently in and if they experienced any side effects After getting treatment with the device they will receive the standard of care treatment for their lymphedema from their provider After the standard of care has concluded the previously mentioned measurements will be repeated This data will be put together and analyzed to look for differences in arm size before and after treatment with the device as well as to look for the prevalence of side effects
Detailed Description:
For each study visit participants will be asked to arrive 45 minutes before the beginning of their regularly scheduled follow-up visit Research activities will take 45 minutes
Upon early arrival to their regularly scheduled appointment participants will be fitted for their very own athletic sleeve by a member of the research team This athletic sleeve will be used throughout the duration of the study Participants will be asked to come wearing a tank top or short-sleeved t-shirt If they do not come dressed as such they will have the opportunity to change in a private space
Before donning the athletic sleeve a member of the research team will measure the participants upper limb circumference and induration and administer a baseline survey using the first section of the Lymphedema Life Impact Scale LLIS - document attached Upper extremity circumference will be measured in centimeters at several points which are palmar crease the wrist below the styloid process wrist 10 cm wrist 20 cm wrist 30 cm and wrist 40 cm Upper extremity induration will be measured at the same points as circumference These measurements are being taken solely for research purposes and should take approximately 3 minutes
The athletic sleeve will be donned by the participant and the novel therapeutic device will be placed over it A standardized sequence of vibratory therapy will be applied Use of this device will not impact standard of care in any way The participant may ask to stop the research session at any time
The athletic sleeve will then be removed and a member of the research team will measure the participants upper limb circumference and induration and administer a survey using the first section of the Lymphedema Life Impact Scale These measurements are being taken solely for research purposes and should take approximately 3 minutes Participants will be asked if they experienced any side effects or adverse effects
Standardized decongestive therapy will be performed by qualified personnel This step takes approximately 1 hour and would happen regardless or whether or not patients are enrolled in this study At the conclusion of the standardized decongestive therapy the measurements and surveys mentioned previously will be repeated Participants will also be asked if they experienced any side effects with the standard of care treatment
This series of steps will be repeated at the participants weekly follow-up visits for four weeks Standardized decongestive therapy for lymphedema is most often performed on a weekly basis and is one of the inclusion criteria for this study Therefore choosing this visit frequency would not greatly alter a participants schedule or ability to perform other daily tasks
If a participant chooses to withdraw from the study early or needs to be removed from the study for their own safety notes will be added to research documentation and the patients electronic medical chart indicating their departure from the study Going forward they would receive standard decongestive therapy as before their participation in the study
Study subject limb circumference induration data and survey data will be analyzed using a paired t-test
Upon early arrival to their regularly scheduled appointment participants will be fitted for their very own athletic sleeve by a member of the research team This athletic sleeve will be used throughout the duration of the study Participants will be asked to come wearing a tank top or short-sleeved t-shirt If they do not come dressed as such they will have the opportunity to change in a private space
Before donning the athletic sleeve a member of the research team will measure the participants upper limb circumference and induration and administer a baseline survey using the first section of the Lymphedema Life Impact Scale LLIS - document attached Upper extremity circumference will be measured in centimeters at several points which are palmar crease the wrist below the styloid process wrist 10 cm wrist 20 cm wrist 30 cm and wrist 40 cm Upper extremity induration will be measured at the same points as circumference These measurements are being taken solely for research purposes and should take approximately 3 minutes
The athletic sleeve will be donned by the participant and the novel therapeutic device will be placed over it A standardized sequence of vibratory therapy will be applied Use of this device will not impact standard of care in any way The participant may ask to stop the research session at any time
The athletic sleeve will then be removed and a member of the research team will measure the participants upper limb circumference and induration and administer a survey using the first section of the Lymphedema Life Impact Scale These measurements are being taken solely for research purposes and should take approximately 3 minutes Participants will be asked if they experienced any side effects or adverse effects
Standardized decongestive therapy will be performed by qualified personnel This step takes approximately 1 hour and would happen regardless or whether or not patients are enrolled in this study At the conclusion of the standardized decongestive therapy the measurements and surveys mentioned previously will be repeated Participants will also be asked if they experienced any side effects with the standard of care treatment
This series of steps will be repeated at the participants weekly follow-up visits for four weeks Standardized decongestive therapy for lymphedema is most often performed on a weekly basis and is one of the inclusion criteria for this study Therefore choosing this visit frequency would not greatly alter a participants schedule or ability to perform other daily tasks
If a participant chooses to withdraw from the study early or needs to be removed from the study for their own safety notes will be added to research documentation and the patients electronic medical chart indicating their departure from the study Going forward they would receive standard decongestive therapy as before their participation in the study
Study subject limb circumference induration data and survey data will be analyzed using a paired t-test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None