Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Phase: NA
Conditions: Orthopedic Disorder
Sponsor: Recovery Force LLC

  
Wearable Technology to Reduce Risk of DVT and 
Increase Patient Compliance 
 
Study Protocol and Analysis Plan 
Clinical Trials.gov NCT04995601 
 
April 30, 2021 
 
 

 
 
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SYNOPSIS 
Title of Study 
Wearable Technology to Reduce Risk of DVT and Increase Patient 
Compliance 
Objectives 
 
Primary: Conduct a randomized comparative study of DVT 
prophylaxis using either standard IPC (Group 1) or the RF MAC system 
(Group 2) in 300 patients after TJR surgery. 
 
Hypothesis 1: During the in-hospital portion of the study, participants 
who use the RF MAC will have at least a 25% higher adherence rate of 
wear time of a fully operational IPC device than those using standard 
IPC devices (control group). 
 
Hypothesis 2: Patients wearing the RF MAC in the first 24 hours 
following surgery will take at least 25% more steps as measured by an 
activity tracker than those patients using standard of care IPC devices. 
 
Hypothesis 3: Patients who use the RF MAC will have a mean gait 
speed at 14 postoperative days that is at least 20% higher than patients 
receiving standard of care as measured by the 4-meter walk test. 
 
Hypothesis 4: The time required for preparing patients to ambulate will 
be 50% less using the RF MAC than standard IPC devices. 
 
Secondary: 1) Measure patient reported outcomes (PRO) of comfort, 
device acceptance and ease-of-use. 2) Collect feedback from nurses and 
physical therapists. 
Planned Number 
of Subjects and 
Duration of 
Involvement 
The total duration of the study is expected to be 18 months (recruitment, 
enrollment, participation, case closeout, analysis, completion of final 
report). This study will include two groups.  Group 1 will serve as the 
control group and will receive standard care. Group 2 is the intervention 
group and will receive the RF MAC system pre-and post-operative care 
and standard mobility targets.  Group 1 will consist of 75 patients at 
each of two sites (total of 150 patients). Group 2 will consist of 75 
patients at each of two sites (total of 150 patients). Patients will be 
assigned to a group by a site Research Coordinator using a random 
numbers generator at their final pre-operative appointment.  
Patient Population 
 
This study will be conducted on Adult patients (age 40-85) who are 
scheduled for a first elective total hip replacement (THR) or first or 
second (opposite knee) elective total knee replacement (TKA). Patients 
will have an anticipated hospital length of stay of 48 hours or less and 
will be discharged to home from the hospital. Enrolled participants must 
be able to perform self-care, have a BMI of between 18 and 39 and a 
calf circumference between 11 and 24.5 inches 

 
 
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Investigational 
Products  
RF Movement and Compressions (MAC) System including a charging 
hub, MAC controllers for each limb, and disposable MAC straps for 
each limb. 
Methodology 
Overview 
 
Once IRB approval has been obtained, the sponsor team, Dr. Karen 
Giuliano (University of Massachusetts) and Dr. M. Terry Loghmani will 
begin training Research Coordinators at two study sites: Tufts Medical 
Center and Eskenazi Hospital. Research Coordinators will establish data 
collection methods (Case Report Forms) in REDCap (an online database 
for research data and surveys) at each site, RF MAC Systems will be 
shipped to the sites, charged and prepared for assignment to patients as 
they are enrolled in the study at their final pre-operative appointment. 
Each site will enroll 150 patients (300 patients total) and patients will be 
randomized in to one of two groups: Control (Group 1) or Intervention 
(Group 2). Participants will receive an identification number and all data 
collected will be password-protected. The study consists of two parts: 
in-patient and at-home. All participants will participate in both parts of 
the study. 
 
In-Patient:  
1. In the pre-operative appointment, the Research Coordinator will 
enroll participants and they will be randomly assigned to a study 
Group (control or intervention) and baseline information will be 
collected on the CRF. 
2. A 4-meter walk test will be performed and the Research Coordinator 
will enter results in the patients CRF. 
3. On the day of surgery, the patient will receive standard of care for 
each site for patients undergoing a THR or TKA. Patients in the 
control group (Group 1) will receive the site’s standard of care IPC 
for DVT prophylaxis. Group 2 (intervention) will receive the RF 
MAC System for DVT prophylaxis. In addition, patients in both 
groups will receive an activity tracker.   
4. In the first 24 hours post-operative, the Research Coordinator will 
visit the patient’s room for observation a total of two times. During 
these visits, the Research Coordinator will visually observe the 
status of the DVT prevention device (control or intervention) to 
determine if it is properly applied to the patient’s lower extremities 
and fully operational. This information will be recorded in REDCap. 
For Group 1 (control), this information will be collected by via 
observation by the Research Coordinator and patient interview.  For 
the MAC System Group 2, this information will be collected 
automatically by the device and recorded by the Research 
Coordinator during the periodic visits.  

 
 
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5. Steps in the first 24 hours will be measured using an activity tracker. 
The Research Coordinator will record mobility data from the tracker 
to the CRF. Patients in Group 2 will also have steps measured 
automatically by the RF MAC System. The Research Coordinator 
will also record mobility reported by the RF MAC system in the 
patient’s CRF.  
6. At least once during the first 24 hours of the in-patient period, the 
Research Coordinator will measure through observation and using a 
stopwatch, the amount of time required by a nurse to prepare the 
patient to ambulate (removing tubes, cords, etc.).  
7. Prior to discharge, the Research Coordinator will conduct a second 
4-meter walk test. Results will be recorded in the patient’s CRF. 
8. As the patient is preparing for discharge, the Research Coordinator 
will ask the care team to complete a brief survey regarding their 
experience with both the standard DVT prophylaxis device and the 
RF MAC System during their hospital stay.   
At Home: Once discharged, patients will continue involvement in the 
study at home. Patients in Group 2 will be sent home with their RF 
MAC System and a “patient packet” that includes a user manual, 
charging station, controllers, additional straps, a list of study contacts, a 
patient self-report journal, instructions for wear time and prescriptive 
mobility, and instructions for returning their devices and activity tracker 
at the end of the study. Patients in Group 1 will be sent home with 
instructions for the standard of care, and instructions on how to return 
their activity tracker. Patients in both groups will receive orders for 
standard of care from their healthcare team. This may or may not 
include IPC DVT prophylaxis for Group 1. Group 2 will receive orders 
for mobility and use of the RF MAC System. In addition, patients in 
both Groups 1 and 2 will receive daily at-home mobility goals from 
their healthcare team.  
9. The Research Coordinator will record the prescribed at-home 
standard of care provided prior to discharge.  
10. Patients in both groups will receive orders for at-home physical 
therapy for a minimum of 14 days, which is standard of care for TJR 
patients discharged to home.  
11. Group 1 will receive standard of care DVT prophylaxis (which may 
be compression stockings, standard IPC or no orders) and a daily 
goal for steps (mobility). Compliance related to DVT prophylaxis 
will be self-reported by the patient in a journal in terms of total 
minutes per day. Compliance with mobility goals will be tracked 
using an activity tracker in addition to being self-reported.   

 
 
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12. Group 2 will receive instructions on how many hours per day to use 
the RF MAC System and a targeted number of steps to achieve per 
day (from healthcare team). Primary compliance data with DVT 
prophylaxis will be self-reported in a patient journal. Data related to 
mobility goals will be collected by the RF MAC System and 
recorded each day by the patient. 
13. A final 4-meter walk test will be administered by the Research 
Coordinator at the 2-week in-office visit and results will be entered 
into REDCap.  
14.  At the end of the study, patients will complete a brief survey 
regarding their experience with both the standard DVT prophylaxis 
device and the RF MAC System during their in-home recovery.  All 
participants will receive $100 as remuneration for their study 
participation and be asked to sign a compensation receipt form. 
Participants at Tufts Medical Center will also receive $21 for 
parking reimbursement.  
15. The home physical therapist will also be asked to complete a brief 
survey.  
 

 
 
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TABLE OF CONTENTS 
1 
INTRODUCTION ..................................................................................................... 8 
1.1 
Overview: Deep Vein Thrombosis, Intermittent Pneumatic Compression and 
Circulation .............................................................................................................. 8 
1.2 
Impact of IPC on General Circulation ..................................................................... 8 
1.3 
Impact of IPC on Femoral Vein Circulation ............................................................ 9 
1.4 
References ............................................................................................................... 9 
2 
DESCRIPTION OF THE INVESTIGATIONAL PRODUCTS ............................. 10 
2.1 
RF Movement and Compressions (MAC) System ................................................. 10 
2.2 
Primary .................................................................................................................. 11 
2.3 
Secondary .............................................................................................................. 11 
4.      STUDY OVERVIEW ............................................................................................. 11 
2.4 
Study Approach ..................................................................................................... 11 
2.5 
Study Duration ...................................................................................................... 16 
3 
STUDY POPULATION ........................................................................................... 16 
3.1 
Sample Size and Target Study Population ............................................................. 16 
3.2 
Recruitment Methods ............................................................................................ 17 
3.3 
Patient Selection .................................................................................................... 17 
4 
STUDY MATERIALS ............................................................................................. 17 
4.1 
Investigational Products and Accessories .............................................................. 17 
4.1.1 
RF Movement and Compressions (MAC) Device .......................................................... 17 
4.1.2 
RF Movement and Compressions (MAC) Device Safety and Handling Issues ............. 18 
4.2 
Other Study Materials ............................................................................................ 18 
5 
STUDY PROCEDURES .......................................................................................... 18 
5.1 
Study Data ............................................................................................................. 18 
5.2 
Procedures for Study Closure ................................................................................ 19 
5.2.1 
Routine study close-out .................................................................................................. 19 
5.2.2 
Suspension or premature termination of the study ......................................................... 19 
6 
DATA QUALITY ASSURANCE ............................................................................ 19 
7 
STATISTICAL METHODS .................................................................................... 19 
7.1 
Determination of Sample Size and Planned Analyses ........................................... 19 
7.2 
Bias Minimization ................................................................................................. 20 
8 
ADVERSE EVENT REPORTING .......................................................................... 20 
8.1 
Non-Device-Associated Adverse Events ............................................................... 20 

 
 
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8.2 
Device-Associated Adverse Events ....................................................................... 21 
8.2.1 
Definition of an unanticipated adverse device effect (UADE) event ............................. 21 
8.2.2 
Reporting of device-associated adverse events .............................................................. 21 
8.3 
Recovery Force Contact for Serious Adverse Event Reporting ............................. 21 
9 
RISK ANALYSIS .................................................................................................... 21 
9.1 
Potential Risks of the Investigational Product and Clinical Investigation .............. 21 
9.2 
Potential Benefits of the Investigational Product and Clinical Investigation ......... 21 
9.3 
Minimization of Risks ........................................................................................... 21 
10 INVESTIGATOR RESPONSIBILITIES ................................................................ 22 
10.1 
Site Qualification and Study Oversight ................................................................. 22 
10.2 
Case Report Forms/Electronic Data Records ......................................................... 22 
10.3 
Access to Source Documents ................................................................................. 22 
10.4 
Financial Disclosure .............................................................................................. 23 
10.5 
Deviations from the Study Protocol ....................................................................... 23 
10.6 
Record Retention ................................................................................................... 23 
10.7 
Publication Policy .................................................................................................. 23 
11 ETHICS AND COMPLIANCE ............................................................................... 24 
11.1 
Investigational Device Exemption ......................................................................... 24 
11.2 
Informed Consent and De-Identification ............................................................... 24 
11.2.1 Prospectively collected data ........................................................................................... 24 
11.3 
IRB Review ........................................................................................................... 24 
11.4 
Confidentiality of Data and Patient Records .......................................................... 24 
11.4.1 Provisions to Protect the Privacy Interests of Participants ............................................... 24 
 
 
 
 
 
 
 
 

 
 
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1 
INTRODUCTION 
1.1 
Overview: Deep Vein Thrombosis, Intermittent Pneumatic Compression and 
Circulation 
 
Deep Vein Thrombosis (DVT) is a blood clot in a deep vein which occurs when venous blood flow 
is decreased. Lower extremity DVT requires immediate medical intervention, as it can cause a 
serious or fatal pulmonary embolus (PE). In the US, DVTs are a leading cause of preventable 
hospital death, affecting 350,000-900,000 patients and an estimated 60,000-100,000 annual 
deaths.1,2 DVTs are the fifth most common reason for hospital readmission, the third most frequent 
complication of total joint replacement (TJR), and is associated with an estimated annual cost of 
$10 billion.3  
      
The risk of DVT is increased in hospitalized patients for a variety of reasons including, 
chemotherapy, surgery, and any condition that causes a general decrease in mobility. Immobility is 
one of the easiest modifiable risk factors for prevention of DVT.  In fact, one recent study showed 
patients spend as much as 95% of waking hours in bed while they recover.4  In fact, DVT is the 
most feared complication of TJR, with more than 300,000 total hip and 700,000 total knee 
replacements performed annually in the U.S.4 Current recommendations for postoperative DVT 
prevention after TJR include anti-coagulant medications and/or external compression of the lower 
limb for a minimum of 10-14 days.5,6  Since the use of anticoagulants increases the risk of bleeding, 
if the same level of DVT prevention can be achieved with the use of external intermittent pneumatic 
compression devices (IPC), patients outcomes could be improved. The degree of enhanced blood 
flow, particularly in the femoral vein, is particularly important for effective DVT prevention, 
therefore, it is important to understand the blood flow enhancement efficacy of the available IPC 
products.  
 
1.2 
Impact of IPC on General Circulation 
 
Some data support that the use of IPC can enhance blood flow throughout the body. Use of a laser 
Doppler flowmetry device has demonstrated that the use of an IPC that covered both the limbs and 
abdomen enhanced blood circulation to the forearms.7 In another study, participants who received 
IPC therapy for 30 minutes twice a day for two consecutive days achieved an average increase in 
mean arterial pressure of 5mmHg, a decrease in HR of 4bpm, a significant increase in peripheral 
vascular resistance index (from 545 [440-1066] to 613 [369-1280] dynes s cm(-5) m(-2) [P = 
0.013]) and reduction in cardiac index (from 3.4 [2.7- 4.5] to 3.2 [2.5-4.0] L/min per m2 [P = 
0.034]).8 
 
A study using an IPC on the thigh was shown to increase levels of oxygenated hemoglobin in 
ischemic limbs of patients with severe peripheral artery disease.9 Traditional foot-calf IPC did not 
exhibit any associated increases in oxygenated hemoglobin. A similar study followed patients with 
critical limb ischemia that were considered amputation-bound. After use of IPC for 12 weeks, mean 
toe pressures increased from 38.2 to 67 mm Hg, popliteal artery flow velocity increased from 45 to 

 
 
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47.9 cm and cumulative survival at 12 months was 81.2% for IPC therapy users, compared with 
69.2% in the control group.10 This study was repeated in 2011 and 2013 with similar results.11,12  
 
1.3 
Impact of IPC on Femoral Vein Circulation 
 
Available data on femoral vein circulation support that circulation can be improved with IPC use.  
One study used both plantar-calf and calf IPC in healthy volunteers and found a significant increase 
in the maximum velocity of the femoral vein after just five minutes of use.13 Another study on 
healthy subjects using the most common type of IPC demonstrated an over 300% increase in 
average peak velocity in the common femoral vein of each limb after each compression cycle.14 In a 
group of inpatients getting prophylactic IPC status post total knee arthroplasty, ultrasonography 
found that blood volume and velocity was increased in both superficial and deep venous systems in 
the thighs.15  
1.4 
References 
1. 
Makic MB, Rauen C, Watson R, Poteet AW. Examining the evidence to guide practice: 
challenging practice habits. Crit Care Nurse. 2014;34(2):28-45; quiz 46. 
2. 
CDC. Venous thromboembolism (blood clots). 2017 
             https://www.cdc.gov/ncbddd/dvt/data.html Accessed July 17, 2018. 
3. 
CDC. Venous thromboembolism (blood clots): Healthcare-associated venous 
thromboembolism. . 2016; https://www.cdc.gov/ncbddd/dvt/ha-vte.html Accessed May 6, 
2018. 
4)  
Hastings, Susan, Zullig, Leah. Mobilizing Hospitals to Mobilize Patients. J Am Geriatr Soc. 
2020 Oct;68(10)2202-4. doi: 10.1111/jgs.16698 
5. 
HCUPnet. Healthcare Cost and Utilization Project. Agency for Healthcare Research and 
Quality. . 2018; http://hcupnet.ahrq.gov. Accessed April 5, 2018. 
6. 
Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery 
patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College 
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 
Suppl):e278S-e325S. 
7. 
Colwell CW, Jr., Froimson MI, Mont MA, et al. Thrombosis prevention after total hip 
arthroplasty: a prospective, randomized trial comparing a mobile compression device with 
low-molecular-weight heparin. J Bone Joint Surg Am. 2010;92(3):527-535. 
8. 
Amah G, Voicu S, Bonnin P, Kubis N. Low-pressure sequential compression of lower limbs 
enhances forearm skin blood flow. Clin Invest Med. 2016;39(6):E204-E212. 
9. 
Fanelli G, Zasa M, Baciarello M, et al. Systemic hemodynamic effects of sequential 
pneumatic compression of the lower limbs: a prospective study in healthy volunteers. 
Journal of clinical anesthesia. 2008;20(5):338-342. 
10. 
Manfredini F, Malagoni AM, Felisatti M, et al. Acute oxygenation changes on ischemic foot 
of a novel intermittent pneumatic compression device and of an existing sequential device in 
severe peripheral arterial disease. BMC Cardiovasc Disord. 2014;14:40. 
11. 
Sultan S, Esan O, Fahy A. Nonoperative active management of critical limb ischemia: initial 
experience using a sequential compression biomechanical device for limb salvage. Vascular. 
2008;16(3):130-139. 

 
 
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12. 
Tawfick WA, Hamada N, Soylu E, Fahy A, Hynes N, Sultan S. Sequential compression 
biomechanical device versus primary amputation in patients with critical limb ischemia. 
Vascular and endovascular surgery. 2013;47(7):532-539. 
13. 
Sultan S, Hamada N, Soylu E, Fahy A, Hynes N, Tawfick W. Sequential compression 
biomechanical device in patients with critical limb ischemia and nonreconstructible 
peripheral vascular disease. Journal of vascular surgery. 2011;54(2):440-447. 
14. 
Iwama H, Obara S, Ohmizo H. Changes in femoral vein blood flow velocity by intermittent 
pneumatic compression: calf compression device versus plantar-calf sequential compression 
device. J Anesth. 2004;18(3):232-233. 
15. 
Labropoulos N, Oh DS, Golts E, Kang SS, Mansour MA, Baker WH. Improved venous 
return by elliptical, sequential and seamless air-cell compression. Int Angiol. 
2003;22(3):317-321. 
16. 
Markel DC, Morris GD. Effect of external sequential compression devices on femoral 
venous blood flow. J South Orthop Assoc. 2002;11(1):2-9; quiz 10. 
 
 
2 
DESCRIPTION OF THE INVESTIGATIONAL PRODUCTS 
2.1 
RF Movement and Compressions (MAC) System 
The RF MAC System is a novel device that is applied to the lower legs of patients that 
provides intermittent active compressions to the calf muscles which results in increased 
blood flow in the veins, moving blood towards the direction of the heart and reducing the risk 
of clot formation.  
 
The Movement and Compressions System is intended to be a portable and wearable system, 
prescribed by healthcare professionals, to treat the following conditions by stimulating blood 
flow in the legs: 
• Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood 
circulation; and, 
• As a prophylaxis for DVT by persons expecting to be stationary for long periods 
of time. 
During use, the system also monitors patient orientation and movement.  It allows healthcare 
providers and users to implement individualized patient management plans for DVT 
prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the 
previous day as a benchmark. The data displayed on the device allows providers to monitor 
the patient’s orientation, and activity, which can be used to identify risk factors for hospital-
acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, 
pneumonia, atrophic muscles, and delirium.  
 
The device can be used in the home or clinical setting. The device is intended for use in an 
adult patient population. 
 

 
 
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STUDY PURPOSE AND AIMS 
The primary purpose of this study is to conduct a multi-site clinical trial of the RF MAC System. 
The study involves two study sites: Tufts Medical Center (Boston, Massachusetts) and Eskenazi 
Hospital (Indianapolis, Indiana). This study is funded by a Phase II SBIR awarded to Recovery 
Force from the National Institutes of Health, National Heart, Lung and Blood Institute (R44-
HL132624-02). 
2.2 
Primary  
Conduct a randomized comparative study of DVT prophylaxis using either standard IPC 
(Group 1) or the RF MAC system (Group 2) in 300 patients after TJR surgery. 
 
Hypothesis 1: Study participants who use the RF MAC will have rates of adherence to wear 
time of a fully operational device that are at least 25% higher than those using standard IPC 
devices. 
 
Hypothesis 2: Patients wearing the RF MAC in the first 24 hours following surgery will take 
at least 25% more steps as measured by an activity tracker than those patients using standard 
of care IPC devices. 
 
Hypothesis 3: Patients who use the RF MAC will have a mean gait speed at 14 postoperative 
days that is at least 20% higher than patients receiving standard of care as measured by the 
4-meter walk test. 
 
Hypothesis 4: The time required for preparing patients to ambulate will be 50% less using 
the RF MAC than standard IPC devices. 
 
2.3 
Secondary  
Measure patient reported outcomes (PRO) of comfort, device acceptance and ease of use and 
measure nurse perceptions of device acceptance and ease of use and collect feedback from 
nurses and physical therapists.  
 
4.      STUDY OVERVIEW 
 
2.4 
Study Approach 
Once IRB approval has been obtained, the RF study team will begin working with site Research 
Coordinators to implement the study. The initial phase will focus on planning and training, 
followed by enrollment of initial patients.  

 
 
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Once patient enrollment begins, each site will recruit at total of 150 patients (75 in control group 
and 75 in intervention group). Inclusion criteria includes adult patients (age 40-85) who are having 
their first elective total hip replacement (THR) or first or second (opposite knee) elective total knee 
replacement (TKA), speak English and are expected a hospital stay of two days or less with plans to 
discharge to home from hospital (not a rehabilitation facility). In addition, participants must be able 
to perform self-care, have a BMI between 18 and 39 and a calf circumference between 11 and 24.5 
inches.  
 
Exclusion criteria includes patients scheduled for a partial joint replacement, TJR revisions, 
emergency surgeries, those with calf deformities that would not allow proper fit for external 
compression devices, or patients who are non-ambulatory, clinically malnourished or 
frail/deconditioned. Finally, vulnerable patients (pregnant women, prisoners, homeless and 
cognitively impaired) and those that do not speak English are excluded from this study. 
Product labeling and materials are currently only available in English. 
 
Table 1: Clinical Study Plan 
Site 
Eskenazi Hospital 
Tufts Medical Center 
Principal Investigator 
J. Watters, MD 
M. Salzler, MD &  
M. Gordon, MD 
Group (1 is Control; 2 is Intervention) 
1 
2 
1 
2 
Targeted Enrollment 
75 
75 
75 
75 
Total Targeted Enrollment per Site 
150 
150 
Total Projected Study Enrollment 
300 
 
Each site will record the total number of patients screened, the number of patients excluded and the 
reason for the exclusion. These screening statistics will be reported to the Sponsor at the conclusion 
of the study.  
 
Study Preparation: 
Training for implementation of the research protocol and all study procedures/documentation forms 
will be provided by Karen Giuliano, PhD, RN. Training for delivering the 4-meter walk test will be 
provided collaboratively by Drs. Karen Giuliano and M. Terry Loghmani.  
 
Product training for the RF MAC device for use in both the hospital and home will be provided to 
the Research Coordinators at each site by the RF clinical training team.  
 
Study materials, including enrollment forms and surveys will be transferred to REDCap at each site. 
Each site will receive the following supplies: 
 
• RF MAC Systems to meet patient enrollment goals 
• Pedometers 
• Waterproof bag for pedometers (worn around the neck) 
• Stopwatch timers 
• Digital height/weight and BMI scale 
• Automated timing gates 

 
 
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• Electrical tape 
• Gait belts 
• Cones 
• Measuring tape 
• Measuring wheel 
• Postage-paid packaging for returning devices 
 
RF will be responsible for the shipping and installation of the RF MAC hardware. The additional 
single patient use leg straps will be shipped to each site by RF throughout the study to meet each 
site’s enrollment cadence. The product must be stored in a cool, dry and locked location until they 
are distributed to participants. Each product package will include a User Manual and the MAC 
Solution brochure. Patients will also receive a paper journal for recording steps and use of the RF 
MAC System during the at-home study period. 
 
In-Patient:  
In the pre-operative appointment, the Research Coordinator will enroll participants and they 
will be randomly assigned to a study group (control or intervention). Patients will be 
assigned a participant number and that number will be recorded on their Informed Consent 
and the CRF. Only the Research Coordinators at each site and the PI will have access to the 
key that connects participant numbers to patient names.  
 
A baseline 4-meter walk test will be performed and the Research Coordinator will enter 
results in the patients CRF. The protocol for the 4-meter walk test is described in the site 
protocols found in Appendix A (Tufts Medical Center) and Appendix B (Eskenazi Hospital).  
 
On the day of surgery, the patient will receive standard of care for each site for patients 
undergoing a THR or TKA. Patients in the control group (Group 1) will receive the site’s 
standard of care IPC for DVT prophylaxis. Group 2 (intervention) will receive the RF MAC 
System for DVT prophylaxis. In addition, patients in both groups will receive an activity 
tracker and corresponding waterproof pouch to hold the activity tracker. The display screen 
of the activity tracker will be covered with tape during the study period. Tape will be 
removed by Research Coordinators and data will be collected from the device at the end of 
the study period.   
 
Research Coordinators will be responsible for providing device training to participants prior 
to discharge. This will be conducted using verbal explanation, demonstration and return 
demonstration. It is expected to require 10-15 minutes to complete training on the RF MAC 
System and review all required study materials, the use of the activity tracker and follow-up 
requirements. 

 
 
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In the first 24 hours post-operative, the Research Coordinator will record the total number of 
minutes that the DVT prevention device (control or intervention) was properly applied to the 
patient’s lower extremities and fully operational. For Group 1, this information will be 
collected via patient interview and Research Coordinator observation. The Research 
Coordinator will visit the patient at least two (2) times in the first 24 post-operative hours 
and visually observe if the DVT devices are on the patient as directed by the standard of 
care, are fully operational and are correctly positioned. The Research Coordinator will note 
visual observations for each visit in the CRF. In addition, the Research Coordinator will ask 
the patient if they have kept their DVT devices on as directed by the healthcare team. The 
patient’s response will be recorded on the CRF.  
 
For Group 2, the MAC System will automatically capture time in use and display results on 
the device. Following the same protocol, the Research Coordinator will visit Group 2 
patients at least two (2) times during the 24 post-operative period to observe if the RF MAC 
is in use, properly positioned (the device will not operate unless it is properly positioned) 
and will record the time displayed for DVT prophylaxis on the patient’s CRF. In addition, 
the Research Coordinator will ask the patient if they have kept the DVT devices on as 
directed by the healthcare team. this information and results will be captured from the device 
display by the Research Coordinator and recorded in REDCap. 
 
For both groups, steps in the first 24 hours will be measured using an activity tracker and the 
Research Coordinator will record this information in REDCap. For patients in Group 2, 
steps will also be measured automatically by the RF MAC System. The Research 
Coordinator will read the display screen on the MAC and record steps taken during the first 
24 post-operative hours.  
 
For both groups, at least once each day during the in-patient period, the Research 
Coordinator will measure through observation and using a stopwatch, the amount of time 
required by a nurse or other healthcare worker to prepare the patient to ambulate (removing 
DVT prophylaxis tubes, cords, etc.). The purpose of ambulation, time required to prepare 
the patient and time required to return the DVT prophylaxis will be recorded on the CRF.  
 
Prior to discharge, the Research Coordinator will conduct a 4-meter walk test and record the 
results in REDCap and include a note of any assistive walking device used during the test. 
The Research Coordinator will also record the information on the display of the RF MAC at 
time of discharge (Group 2 only) and the number of steps on the activity tracker. 
 
As patients in Group 2 are preparing for discharge, the Research Coordinator will coordinate 
survey completion for the patient and members of the care team (nurses, physical therapists, 
etc.). 
 
Patients will receive at home orders for DVT prophylaxis, physical therapy and mobility 
goals. These orders will be recorded in the patient’s CRF by the Research Coordinator. 
Group 1 will receive standard of care DVT prophylaxis (to be noted in the CRF) and Group 
2 will take the RF MAC home to continue DVT prevention using the device.  

 
 
15
 
At Home:  
Once discharged, patients will continue involvement in the study at home.  
 
Patients in both groups will receive orders for standard of care from their healthcare team. 
This may or may not include IPC DVT prophylaxis for Group 1. Group 2 will receive orders 
for use of the RF MAC System. Patients in Group 2 will be sent home with their RF MAC 
System and a “patient packet” that includes a user manual, charging hub, controllers, 
additional straps, a list of study contacts, and instructions for returning their devices at the 
end of the study. Patients in Group 1 will be sent home with the standard of care (as noted in 
their CRF) 
 
In addition, patients in both Groups 1 and 2 will receive daily at-home mobility goals from 
their healthcare team (which were noted in the CRF at discharge).  
 
Patients in both groups will receive orders for at-home physical therapy for a minimum of 
14 days, which is standard of care for TJR patients discharged to home. The Research 
Coordinator will record prescribed physical therapy in the patient’s CRF. 
 
Group 1 will receive standard of care DVT prophylaxis (which may be compression 
stockings, standard IPC or no orders) and a daily mobility goals. Daily mobility goes are 
expected to prepare patients to complete 2,000 steps a day by the end of the 2-week study 
period. Compliance will be measured using the activity tracker provided at study enrollment. 
Patients will be asked to wear the tracker at all times, except during sleep. At the conclusion 
of the study, the Research Coordinator will record the total activity per day. In addition, the 
Research Coordinator at each site will call study participants two times during each week of 
study participation to ensure participants are wearing the activity trackers.   
 
Group 2 will receive instructions on how many hours per day to use the RF MAC System 
and a targeted number of steps to achieve per day (from healthcare team). Primary 
compliance data will be self-reported and collected by the Research Coordinator. Data 
related to mobility goals will also be collected with the activity tracker. A secondary method 
of data collection will be the RF MAC System itself. At the end of each day, patients in 
Group 2 will record the data on the display of the RF MAC System screen, filling in the data 
for each category in a paper diary provided by the Research Coordinator (provided to 
Coordinators by Recovery Force). The paper diary will include an image of the screen and 
users will write the data they see on the screen at the end of each day.  
 
The Research Coordinator will call each participate (in both groups) two times a week 
during the two-week study. Telephone calls will focus on 1) reminding patients to comply 
with orders; 2) reminding patients to wear their activity tracker; and 3) reminding patients to 
comply with DVT prevention orders. The Research Coordinator will answer any questions 
and confirm the participants are complying with study requirements. The Research 
Coordinator will also review with the patient the return procedures for the RF MAC, which 
will involve bringing the device with them to their two-week post-operative office visit.  
 

 
 
16
The patients in both groups will be reminded the day before their 2-week appointment via a 
telephone call to bring their activity tracker with them to their appointment. The patients in 
Group 2 will be reminded to also bring back the RF MAC System in its entirety with them 
to their appointment.  
 
At the 2-week follow up appointment, the Research Coordinator will conduct a final 4-meter 
walk test. Results will be recorded on the patient’s CRF in REDCap.  
 
Once the walk test is complete, the Research Coordinator will direct the patient to complete 
a final survey. Next, the patients will return all study equipment (activity tracker and the RF 
MAC System) to the Research Coordinator.  Patients who return all equipment will receive 
their $100 remuneration for study participation. Renumeration will be reduced by 50%  to 
$50.00 for any patients who do not return their equipment. Patients who did not return the 
devices will receive a postage-paid package for returning both the activity tracker and RF 
MAC device to Recovery Force. Once the equipment has been received by Recovery Force, 
the additional $50 remuneration will be mailed to the participant. In addition, participants at 
Tufts Medical Center will receive $21 stipend as reimbursement for parking costs.  
 
Research Coordinators will also send at-home physical therapists of individuals in Group 2 a 
link to a brief survey about the RF MAC.  
2.5 
Study Duration 
The total duration of the study is expected to be 18 months (site training, recruitment, enrollment, 
participation, case closeout, analysis, completion of final report). This study will include two 
groups.  Group 1 will serve as the control group and will receive standard care. Group 2 is the 
intervention group and will receive standard care and the proposed intervention, the RF MAC 
System. Group 1 will consist of 75 patients at each of two sites (total of 150 patients). Group 2 will 
consist of 75 patients at each of two sites (total of 150 patients). Patients will be assigned to a group 
by a site Research Coordinator using a random numbers generator at their final pre-operative 
appointment.  
3 
STUDY POPULATION 
3.1 
Sample Size and Target Study Population 
The following vulnerable patients will be excluded from the study: pregnant women, prisoners, 
homeless and cognitively impaired.  Data will be collected at two locations, one site for each 
cohort.  
 
Each of the two study sites are responsible for recruiting participants in the study (150 total 
participants, with 75 in each of two study groups).  

 
 
17
3.2 
Recruitment Methods 
Study recruitment at each site will be coordinated with the pre-op team. The initial recruitment will 
occur during the pre-op visit. Surgeons will recruit patients using direct referral from within the 
PI/Co-investigator’s own clinic and inform them of the study, and ask if they are interested in 
participating. If the patient is interested, the Research Coordinator will complete the Informed 
Consent process with the subject and explain the study and answer all questions. This will include 
reviewing and signing consent.  
 
Patients will be provided a consent form describing the study and containing sufficient information 
to make an informed decision about participation. Patients who decide to participate will sign the 
IRB approved consent form and the subject in order to process the payment at the end of the study. 
Tufts Medical Center uses the CliniCard system, which is a pre-loaded debit card that subjects will 
be given a copy for their records, at the end of their post-operative appointments when all 
interventions and surveys have been completed and the device has been returned. Study participants 
will receive a review of study participation requirements at the anesthesia appointment.  
3.3 
Patient Selection 
The eligibility criteria for prospective enrollment of subjects are shown in Table 1.  
Table 2: Inclusion/Exclusion Criteria for Enrollment of Subjects 
Inclusion  This study will be conducted on adult volunteers, aged 40-85 years who speak 
English. 
Exclusion 
The following vulnerable patients will be excluded from the study: pregnant 
women, prisoners, homeless and cognitively impaired. Individuals who do not 
speak English will be excluded from this study. 
4 
STUDY MATERIALS 
4.1 
Investigational Products and Accessories 
4.1.1 
RF Movement and Compressions (MAC) Device 
The RF MAC Device is a novel device that is applied to the lower legs of patients that 
provides intermittent active compressions to the calf muscles which results in increased 
blood flow in the veins, moving blood towards the direction of the heart and reducing the risk 
of clot formation.   
The Movement and Compressions System is intended to be a portable and wearable system, 
prescribed by healthcare professionals, to treat the following conditions by stimulating blood 
flow in the legs: 
• Aid in the prevention of DVT (deep vein thrombosis); 
• Enhance blood circulation; 
• As a prophylaxis for DVT by persons expecting to be stationary for long periods of 
time. 
 

 
 
18
During use, the system also monitors patient orientation and movement.  It allows healthcare 
providers and users to implement individualized patient management plans for DVT 
prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the 
previous day as a benchmark. The data displayed on the device allows providers to monitor 
the patient’s orientation and activity, which can be used to identify risk factors for hospital-
acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, 
pneumonia, atrophic muscles, and delirium.  
 
The device can be used in the home or clinical setting. The device is intended for use in an 
adult patient population. 
 
4.1.2 
RF Movement and Compressions (MAC) Device Safety and Handling Issues 
The Recovery Force MAC System consists of three components: the strap, designed for single 
patient use; and the controller, designed for multi-use, and the charging hub. If you are, or may be, 
pregnant, do not use. Recharge battery using an outlet readily accessible for quick disconnect. Do 
not use where aerosol (spray) products are being used or oxygen is being administered. 
Electromedical devices have the potential for explosion in these situations. Never use pins or other 
metallic fasteners with this product as these could damage the wiring of the device. Care must be 
taken when operating this equipment around other equipment to avoid reciprocal interference. 
Potential electromagnetic or other interference could occur to this or to the other equipment. Try to 
minimize this interference by not using other equipment in conjunction with this device. Keep and 
store when not in use out of reach of children, pets, pests, and away from water. No modification of 
this equipment is allowed. No user serviceable parts inside. If you experience pain, swelling, 
sensation changes, discomfort or any unusual reactions (including allergic reactions to the materials 
in this device) while using the device, stop using the device and consult your physician 
immediately. If pulsing or throbbing occur, the device may be wrapped too tightly. Loosen 
immediately.  This device should not be used adjacent to or stacked upon other devices.  
4.2 
Other Study Materials 
 
Study notebooks to maintain study documents, including signed Informed Consents and all 
applicable information, and additional forms to be collected and retained by the study institution 
during the course of the study and maintained for three (3) years following the study completion 
date.  
5 
STUDY PROCEDURES 
5.1 
Study Data 
Eligible subjects will be invited to participate in the study using a convenience sampling strategy. 
Potential subjects must provide informed consent to participate. To be eligible for participation, 
subjects must speak English and be between the ages of 40-85. 

 
 
19
5.2 
Procedures for Study Closure 
5.2.1 
Routine study close-out 
The study will end when Recovery Force has obtained all data necessary to complete its studies of 
the test products. Study close-out will follow Recovery Force standard procedures and may include, 
but is not limited to, review of regulatory documents, collection of completed case report forms, 
reconciliation of study records, removal or destruction of ancillary study supplies, record retention 
and final report submission to the IRB. 
5.2.2 
Suspension or premature termination of the study  
This study may prematurely terminate at any time because of a regulatory authority decision, a 
change in opinion of the IRB, or at the discretion of Recovery Force. If the study is temporarily 
suspended, Recovery Force will provide guidance on timing and procedures for resuming the study. 
If the study is prematurely discontinued, all study materials must be collected, and all study forms 
completed to the extent possible.   
 
6 
DATA QUALITY ASSURANCE  
Study monitoring is planned at 6 months.  The Principal Investigator will be responsible for the 
accuracy of all study data.  
 
7 
STATISTICAL METHODS 
7.1 
Determination of Sample Size and Planned Analyses 
Dr. Karen Giuliano (University of Massachusetts) is responsible for statistical design and power on 
this study.  First, the team will test the group differences on demographic profiles and between 
RF1400 (Group 2) and standard-of-
care (Group 1). If unbalances on any 
of these characteristics exist, the 
Horvitz-Thompson weights or 
propensity scores will also be adjusted 
to adjust for bias (d’Agostino, 1998). 
Dr. Giuliano will also compare the 
characteristics of the individuals who 
will drop out of the study with those 
who complete the study and create 
weights to adjust for any potential bias. 
For study, Recovery Force 
hypothesizes that the in-hospital 
outcomes measures (minutes of use in 
the first 24 postoperative hours, 
number of steps in the first 24 
postoperative hours and the amount of 
200
300
400
500
600
700
.25
.3
.35
.4
.45
Experimental-group mean (
2)
.8
.9
Power (1- )
Parameters:  = .05, 
1 = 0,  = 1
t test assuming 
1 = 
2 = 
H0: 
2 = 
1  versus  Ha: 
2  
1
Estimated total sample size for a two-sample means test

 
 
20
time required by acute care nursing staff to get the patient ready to ambulate) for the patients in 
RF1400 group (Group 2) will significantly outperform those in standard IPC prophylaxis group 
(Group 1). Similarly for the Aim 2 at-home outcome measures, (minutes of use per day in the first 
14 days of at home use and gait speed at 14 days using the 4-meter walk test, Recovery Force 
hypothesizes that patients in RF1400 group (Group 2) will significantly outperform those in 
standard of care group (Group 1). All outcomes are continuously measured. To test Aim 2, let E1 
be the indicator variable of group 1 (E=1) vs. group 2 (E1=0), and Y stands for the outcome 
variable, Z refers to other relevant background and/or clinical variables (age, gender, 
comorbidities, etc.), the  analysis of covariance (ANCOVA) model will be used to assess the 
difference between groups, i.e., and the team will have Y = β0 + β1E1 + β2Z + ε,  estimated to give 
corresponding b parameters for β by ordinary regression.  The significance of coefficient of β1 will 
be tested to show the group differences.  The interaction term of treatment indicator and center 
indicators will also be tested to examine the homogenous treatment effect across the two study 
sites. The study was powered assuming 80% of power and 0.05 significance level; the study will 
require 130 patients per group to detect a medium effect size (EF) of 0.35 difference between 
groups for a continuously measured outcome. Assuming up to a 15% dropout, each site will enroll 
150 patients in each group. The graph below shows the different sample size requirements to 
detect a certain EF at power of 0.8 or 0.9.  
7.2 
Bias Minimization 
All subjects meeting the specified eligibility criteria will be enrolled using a convenience sampling 
strategy.  
 
8 
ADVERSE EVENT REPORTING 
8.1 
Non-Device-Associated Adverse Events 
Adverse events occurring during the enrollment period should be documented by the Investigator in 
progress notes but will not be collected or analyzed by Recovery Force unless considered serious.  
 
Serious adverse events (SAEs) encountered during study enrollment will be documented by the 
Investigator and reported to Recovery Force immediately upon discovery. SAEs are defined under 
current Good Clinical Practice (cGCP) guidelines as events that result in one or more of the 
following: 
 
• life-threatening illness or injury;  
• permanent impairment of a body structure or a body function;  
• medically necessary in-patient hospitalization;  
• medical or surgical intervention necessary to prevent permanent impairment to body 
structure or function; or  
• fetal distress, fetal death, or congenital abnormality. 
 
SAEs will be reported using an Unanticipated Adverse Device Effects (UADE) form which serves 
the dual role of capturing pertinent SAE information per industry guidelines and capturing device 

 
 
21
information pertinent to medical device standards. Other serious events that affect the rights, safety, 
or welfare of subjects must also be documented on the UADE form and must be reported 
immediately to Recovery Force and to the Investigator’s IRB according to that IRB’s policies. 
8.2 
Device-Associated Adverse Events  
8.2.1 
Definition of an unanticipated adverse device effect (UADE) event 
A UADE event, as defined by cGCP guidelines, is any SAE, life-threatening problem, or death 
caused by or associated with a device (or with the process of evaluating a device) if that SAE, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated, serious, device-associated problem that relates to the rights, safety, or welfare of 
subjects or operators using the investigational product system or the comparator product system. 
8.2.2 
Reporting of device-associated adverse events 
The Investigator will be responsible for reporting any UADEs to Recovery Force and to the 
Investigator’s reviewing IRB. UADEs will be documented by the Sponsor on UADE forms. 
8.3 
Recovery Force Contact for Serious Adverse Event Reporting 
 
 
9 
RISK ANALYSIS 
9.1 
Potential Risks of the Investigational Product and Clinical Investigation 
All subjects will be entering the study voluntarily and the nature of this study should involve 
minimal risk for study subjects.   The only anticipated risks include the possibility of discomfort 
with the use of the RF MAC Device and potential for feeling uncomfortable with legs exposed 
during the data collection process. . There is also potential for lack of patient satisfaction with the 
device. 
 
9.2 
Potential Benefits of the Investigational Product and Clinical Investigation 
It cannot be promised that you will receive any medical benefits from being in this study. 
 
9.3 
Minimization of Risks 
Patients who experience discomfort with the device can discontinue use immediately to avoid 
further discomfort.  
 
Jason Bobay 
jbobay@recoveryforceusa.com 
317-719-5359 

 
 
22
10 INVESTIGATOR RESPONSIBILITIES 
10.1 
Site Qualification and Study Oversight 
The PI is responsible for general administration of the study. Before the study, the PI must: 
 
• Sign the Protocol Signature Page  
• Provide financial disclosures to Recovery Force, per Title 21CFR 54 (see Section 12.4 
below).  
 
During the study, the PI must ensure that: 
 
• The study is conducted ethically;  
• Case report forms (CRFs), including Subject informed consents, are provided with each 
transfer of data requiring informed consent; and 
• All other study forms are completed as outlined by this study protocol. 
 
In the case of completion or termination of the study or an Investigator's role in the study, all study 
materials must be returned to Recovery Force. 
10.2 
Case Report Forms/Electronic Data Records 
As used in this protocol, the term CRF should be understood to refer to either a paper form or an 
electronic data record or both, depending on the data collection method(s) used. 
 
Original CRFs are the sole property of Recovery Force and should not be made available in any 
form to third parties, except for authorized representatives of Recovery Force or appropriate 
regulatory authorities, without written permission from Recovery Force.  
 
It is the PI's responsibility to ensure completion, review, and approval of all CRFs. CRFs must be 
signed by the PI or by an authorized staff member. These signatures serve to attest that the 
information contained on the CRFs is true. At all times, the PI has final personal responsibility for 
the accuracy and authenticity of all clinical and laboratory data entered on the CRFs.  
10.3 
Access to Source Documents 
Recovery Force or its agents and appropriate regulatory authorities shall be granted direct access to 
all study-related documents to perform verification that the protocol and all applicable Good 
Clinical Practices (GCPs), and regulations are being followed and to confirm that study documents 
are complete and accurate. It is important that Investigator(s) and their relevant personnel be made 
available during monitoring visits and any audits or inspections, and that sufficient time is allotted 
for the process.  

 
 
23
10.4 
Financial Disclosure 
Investigators must provide Recovery Force with sufficient, accurate financial information in 
accordance with local regulations to allow Recovery Force to submit complete and accurate 
financial certification or disclosure statements to the appropriate health authorities. Investigators are 
responsible for providing information to Recovery Force concerning their relevant financial 
interests during the course of the study and for one year after completion of the study. Conflicts of 
interest should be disclosed as required by law.  
 
Recovery Force is the sponsor of this study. This study is funded by a Phase II SBIR awarded to 
Recovery Force from the National Institutes of Health, National Heart, Lung and Blood Institute 
(R44-HL132624-02).  
10.5 
Deviations from the Study Protocol 
An Investigator may not deviate from the study protocol without prior approval by Recovery Force 
unless the deviations are necessary under emergency circumstances to protect the rights, safety, or 
well-being of human subjects or the scientific integrity of the clinical investigation. These 
deviations must be documented and promptly reported to Recovery Force and, if applicable, to the 
IRB providing oversight of the study. Protocol deviations may result in corrective and preventive 
actions and/or disqualification of the Investigator.  
10.6 
Record Retention 
To enable evaluations and/or audits from regulatory authorities or Recovery Force, the PI and all 
sub-investigators agrees to retain all study records, including copies of all CRFs, UADE forms, and 
source documents, for three (3) years following completion of the project dependent upon the study 
data. The Investigator must obtain written permission from Recovery Force before disposing of any 
records, even if retention requirements have been met. 
 
If an Investigator relocates, retires, or for any other reason withdraws from the trial, Recovery Force 
must be notified in advance, and study records must be transferred to a designee acceptable to 
Recovery Force. This designee might be another Investigator, another institution, or Recovery 
Force itself. 
10.7 
Publication Policy 
The results of this study may be submitted for publication to a medical journal.  The PI agrees that 
any publication of data from this study will comply with Recovery Force publication policy, the 
instructions to authors outlined by the editor of the journal or conference proceedings where the 
data is to be published, and the spirit of recommendations made in the good publication practice 
guidelines (GPP3) of the International Society of Medical Publication Professionals. Recovery 
Force has the right to review any manuscripts, presentations, or abstracts that originate from this 
study or that utilize these data before they are submitted for publication or other means of 
communication.  

 
 
24
11 ETHICS AND COMPLIANCE 
11.1 
Investigational Device Exemption 
Although exempt from IDE regulations as noted in Title 21 CFR 812.2(c), the conduct and 
performance of this study will be in accordance with applicable Recovery Force and Investigator 
responsibilities as described in Title 21 CFR 809 and Title 21 CFR 812. 
11.2 
Informed Consent and De-Identification  
11.2.1 
Prospectively collected data 
 
All subjects will be given a copy of the IRB-approved informed consent form (ICF) to review 
before their study participation begins. The Research Coordinator will explain all aspects of the 
study in lay language and answer all of the potential participant’s questions regarding the study. If 
the participant decides to participate in the study, s/he will be asked to sign and date the ICF. 
Subjects who refuse to participate or who withdraw from the study will be treated without 
prejudice. 
11.3 
IRB Review 
The PI is required to obtain IRB oversight of the research study. The IRB must be provided with the 
Recovery Force-approved study protocol. Performance of the study may not begin until written 
evidence of IRB approval has been provided to Recovery Force.  
 
The conduct and performance of this study will be in accordance with applicable Recovery Force 
and Investigator responsibilities as described in Title 21 CFR 812 and other Good Clinical Practice 
guidance.  
 
IRB/Ethics Committee oversight will be required as human subjects or data from humans are being 
used. This protocol and the associated informed consent document(s) (if applicable) must be 
submitted to the IRB for review and approval. Performance of the study at a given site may not 
begin until written evidence of IRB oversight has been provided to Recovery Force study manager. 
IRB Review and approval must comply with Title 21 CFR 812 Subpart D. 
11.4 
Confidentiality of Data and Patient Records 
All patients who are enrolled will be assigned an identification number.  A list of participant names 
and their corresponding medical record numbers and participant identification numbers will be kept 
in a password protected file. Only the research team members and Principal Investigator will have 
access to this information.  
11.4.1 Provisions to Protect the Privacy Interests of Participants 
The PI and/or study institution shall provide sufficient information to allow the IRB to evaluate the 
researcher’s provisions to maintain the confidentiality of data. 
 

 
 
25
Privacy data will be maintained in accordance with HIPAA and other applicable policies  and local 
law.