Clinical trial NCT05537883
Conditions: Morbid Obesity Bariatric Surgery Candidate
Keywords: Transversus Abdominis Plane (TAP) block Bupivacaine Liposomal bupivacaine
Sponsor: Wake Forest University Health Sciences
Start date: 2022-11-29; Completion date: 2023-12-07
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.

Detailed description:
Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Arms: arm 1: Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution. arm 2: Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Bupivacaine Injection
Intervention descriptions: intervention 1: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine intervention 2: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Protocol documents:
Prot_SAP_000.pdf: 
TAP Block Study
NCT05537883
IRB Approval Date:  07AUG2023


Bariatric Exparel TAP Block Study 
Date: 8/4/2023 
1 
Study Title: Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using 
Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients 
Principal Investigator: Selwan Barbat 
Co-Investigators: Paul Chandler, Elizabeth Santone 
Sponsor or funding source: Wake Forest University Health Sciences 
Background, Rationale, and Context 
The transversus abdominis plane (TAP) block was described in 2007 using an ultrasound 
to inject local anesthetic between the internal oblique and transversus abdominis muscles where 
the sensory nerves of the abdominal wall travel [1]. The TAP block can also be performed by the 
surgeon with laparoscopic guidance. TAP block has been shown to provide analgesia after ab-
dominal surgery, decreasing opioid use, and is widely accepted into practice [2]. TAP block has 
become a cornerstone in enhanced recovery after surgery programs, as well as part of multi-
modal analgesia, and opioid reducing efforts nationwide. A recent meta-analysis of Randomized 
Controlled Trials (RCT) comparing TAP block with bupivacaine or ropivacaine to no TAP block 
in bariatric surgery showed reduced postoperative nausea and vomiting and time to ambulation 
[3]. Liposomal bupivacaine compared to plain bupivacaine has been touted to provide a longer 
duration of analgesia (up to 72 hours) by slowly releasing the anesthetic agent into local tissue. A 
recent systematic review comparing liposomal bupivacaine to conventional local anesthetic 
agents in regional anesthesia, including TAP blocks, showed conflicting results so no definitive 
conclusions could be made [4]. It is unclear if liposomal bupivacaine is superior to plain bupiva-
caine for TAP blocks in bariatric surgery. Our study would be the first RCT comparing laparo-
scopic TAP block with liposomal bupivacaine vs plain bupivacaine in a bariatric surgery popula-
tion.  
Objectives 
Compared to only Bupivacaine administered via TAP block, we will investigate the anal-
gesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a 
Liposomal Bupivacaine mixture.     
Primary Objective: To determine if patients undergoing metabolic and bariatric surgery 
receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual 
analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupi-
vacaine only.  
Primary Hypothesis: 
1) Lower values of the outcome variable VAS are desirable, and the hypothesis
is listed below –


Bariatric Exparel TAP Block Study 
Date: 8/4/2023 
2 
Hypothesis 1. 1  
𝐻𝐻0: 
 𝜇𝜇𝐸𝐸−𝜇𝜇𝑆𝑆  ≥𝛿𝛿  (Study group is different compared to the active 
control group      by 𝛿𝛿 or more) 
𝐻𝐻1: 
 𝜇𝜇𝐸𝐸−𝜇𝜇𝑆𝑆  < 𝛿𝛿 (Study group is equivalent to the active control when 
difference is within prespecified 𝛿𝛿) 
Where 𝜇𝜇𝐸𝐸, 𝜇𝜇𝑆𝑆  are the population means for the outcome VAS measured at 24 
hours after surgery for the study group (E) and the standard (S) active group, re-
spectively  
𝛿𝛿 is non-inferiority margin, specified in advance based on clinical judgement. 
Based on our clinical experience, 𝛿𝛿 = 1.5 
Secondary Objectives: Compared to TAP block with Bupivacaine only, we will compare 
opioid consumption, and other effect differences to patients undergoing metabolic and bariatric 
surgery receiving TAP block with Liposomal Bupivacaine.     
Secondary Hypotheses 
Hypothesis 2.1 – Patients undergoing metabolic and bariatric surgery receiving 
TAP block with Liposomal Bupivacaine results in less opioid consumption before hospi-
tal discharge /during the first 48 hours postoperatively as measured in morphine equiva-
lents (mg) compared to patients receiving simply TAP block with Bupivacaine only.  
Hypothesis 2.2 - Patients undergoing metabolic and bariatric surgery receiving 
TAP block with Liposomal Bupivacaine results in pain score as measured by visual ana-
logic scale (VAS) at 12 hours after surgery that are equivalent compared to patients re-
ceiving TAP block with Bupivacaine only.  
Exploratory objectives: We will explore other effects, including pain score at 48 hours, 
and 72 hours after surgery, total opioid consumption required post op during their one-week post 
op visit as measured in morphine equivalences. 
Methods and Measures 
Design 
This study is a 2-arm parallel single blinded randomized equivalency, single-cen-
ter, clinical trial.  Patients will be blinded to type of TAP block used.  
Setting 
This study will take place at Atrium Health, an academic medical center. 
Subjects selection criteria 


Bariatric Exparel TAP Block Study  
 
Date: 8/4/2023 
3 
Inclusion Criteria 
To be eligible for enrollment in this study, participants must meet all the following 
criteria: 
1. Adult, age > 18 years 
2. Participants who can give written informed consent and willing to comply with all 
stud-related procedures. 
3. Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass 
Exclusion Criteria 
1. Patients undergoing duodenal switch procedures 
2. Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or 
cholecystectomy at time of primary metabolic surgery 
3. Patients with chronic opioid use 
Sample Size 
The number of patients required in each group is determined from a power analysis based 
on primary hypothesis.  
In this study, based on our clinical experience, we assume standard deviation for each 
group is 3, the margin of equivalence is 1.5 on NRS, and the true difference between the two 
groups is 0 on the NRS. Group sample size of 88 from each group achieves 90% power to detect 
our prespecified equivalence margins, with alpha of 0.05.  Assuming a 20% dropout or with-
drawal based upon previous experience, 106 subjects per group will be required.   
 
Interventions and Interactions 
 
There will be two groups: (1) active control and (2) study group. Active control group pa-
tients receive TAP block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, 
and 100 mL normal saline solution. Study group patients will receive TAP block with a Liposo-
mal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, 
and 100 mL normal saline solution. TAP block technique will be standardized using subcostal as 
well as anterior axillary line as landmarks, injecting down to level of T10, using laparoscopic-
guided approach. TAP block will be administered at the start of every case, after the first port is 
placed upon laparoscopy. Type of anesthesia administered will also be standardized including 
the use of narcotics, lidocaine, inhalational anesthesia and Ketamine. 
 
Randomization schedules will be generated by SAS 9.4 (SAS Institute Inc., Cary, NC) by 
using a masked block randomization procedure. Eligible patients will be randomized with a 1:1 
ratio between the 2 groups of patients receiving TAP block Exparel mixture or simply bupiva-
caine administered via TAP block. Research Electronic Data Capture (REDCap) randomization 


Bariatric Exparel TAP Block Study  
 
Date: 8/4/2023 
4 
module will be used to manage randomization and allocate treatment groups. The allocation se-
quence will be concealed with application of the REDCap.  
 
Outcome Measure(s) 
Primary Outcome measures 
1. Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging 
from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could image. 
Secondary Outcome Measures 
1. Pain scores at 12 hours, 48 hours, and 72 hours post-operatively.  
2. Morphine milligram equivalences consumed during hospital stay 
3. Morphine milligram equivalences prescribed and consumed as measured at one week 
follow up clinic visit 
4. Post-operative nausea and vomiting (PONV) measured by a numerical score (1: no 
nausea or vomiting, 2: some nausea no vomiting, 3: nausea and vomiting) 
5. Length of stay in hours 
6. Patient satisfaction score 
These parameters will be scored via SeamlessMD on a phone application, as well as pa-
per and pen on a standardized reporting form for patients less comfortable using technology. 
Data will also be collected from patient electronic charts.  
 
Analytical Plan 
 
Equivalency test with priori specified non-inferiority region will be used to assess pri-
mary outcome variables. 
Descriptive statistics (mean, range, percentage, median, etc.) will be used to assess the quality 
and accuracy of the administrative and clinical data. Means with standard deviations or medians 
with interquartile range (IQR) will be reported for continuous variables and percentages for cate-
gorical variables. Missing data will be evaluated prior to data modeling. General linear regres-
sion, or other generalized linear regression models will be used to compare the outcomes be-
tween the two groups with both univariate or multivariate analyses. Potential confounders will be 
identified with univariate analysis. For univariate analyses, a Student’s t-test or Wilcoxon two-
sample test will be used for continuous variables, and chi-square test for categorical variables 
against the primary and secondary outcomes. Both unadjusted and adjusted odds ratio (OR) with 


Bariatric Exparel TAP Block Study  
 
Date: 8/4/2023 
5 
corresponding 95% confidence interval (CI) will be reported. Two-tailed p values will be calcu-
lated for all tests, and p< 0.05 is considered statistically significant. All data will be analyzed us-
ing Statistical Analysis Software, version 9.4 (SAS Institute Inc., Cary, NC). 
There are no plans for interim data analyses. Analyses will be conducted according to per-proto-
col (PP) principle. 
 
Human Subjects Protection 
Subject Recruitment Methods 
Patients who are scheduled for sleeve gastrectomy or roux-en-y gastric bypass will be identified 
and recruited for the study at the Atrium Health Weight Management clinics during their pre-
operative visit. The bariatric surgeons and bariatric surgery fellows will do the recruiting, and pa-
tients will be contacted directly face to face during the preoperative visit about the study. Patients 
will also receive a written flyer containing information about the study during the preoperative 
visit. As all qualifying patients will be informed about the study during the preoperative visit, ac-
cess to participation among women and minorities will depend on how many of these patients 
undergo sleeve gastrectomy or roux-en-y gastric bypass at our institution. Subject’s privacy will 
be protected by storing records of Protected Health Information in locked facilities or password 
protected computers. Data will be stored on a password protected computer of the investigator 
and in a password protected RedCap database. 
 
Informed Consent 
Signed informed consent will be obtained from each subject. The investigators as well as the 
other bariatric surgeons and bariatric surgery fellows will obtain informed consent at the Atrium 
Health Weight Management clinics during the preoperative visit. 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study out-
comes, minimizing to the fullest extent possible the collection of any information that could di-
rectly identify subjects, and maintaining all study information in a secure manner. To help ensure 
subject privacy and confidentiality, only a unique study identifier will appear on the data collec-
tion form. Any collected patient identifying information corresponding to the unique study iden-
tifier will be maintained on a linkage file, store separately from the data. The linkage file will be 
kept secure, with access limited to designated study personnel. Following data collection subject 
identifying information will be destroyed (state the anticipated time the data will be destroyed, 
e.g. three years after closure of the study, and the method of destruction), consistent with data 
validation and study design, producing an anonymous analytical data set. Data access will be 
limited to study staff. Data and records will be kept locked and secured, with any computer data 


Bariatric Exparel TAP Block Study  
 
Date: 8/4/2023 
6 
password protected. No reference to any individual participant will appear in reports, presenta-
tions, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants. The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the re-
search team to the IRB and sponsor or appropriate government agency if appropriate. 
 
References: 
1. McDonnell JG, O’Donnell BD, Farrell T, et al. Transversus abdominis plane block: a cadav-
eric and radiological evaluation. Reg Anesth Pain Med. 2007;32:399–404  
2. Mukhtar K, Singh S. Transversus abdominis plane block for laparoscopic surgery. Br J 
Anaesth. 2009;102:143–4.  
3. Hytham K.S. Hamid, Amjed Y. Ahmed, Alan A. Saber, Sameh H. Emile, Mohamed Ibrahim, 
Jaime Ruiz-Tovar. Transversus abdominis plane block using a short-acting local anesthetic re-
duces pain and opioid consumption after laparoscopic bariatric surgery: a meta-analysis, Surgery 
for Obesity and Related Diseases. Volume 16, Issue 9. 2020, Pages 1349-1357  
4. Jin Z, Ding O, Islam A, Li R, Lin J. Comparison of liposomal bupivacaine and conventional 
local anesthetic agents in regional anesthesia: A systematic review. Anesth and Analg. 2021; 132 
(6): 1626-34. 
 
Appendix 
1. Consent form 
2. Copy of Seamless MD Daily Health Check surveys 
 
 
 
 


Bariatric Exparel TAP Block Study  
 
Date: 8/4/2023 
7 
 
 

ICF_001.pdf: 
TAP Block Study
NCT05537883
IRB Approval Date:  08.31.2023


Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal 
Bupivacaine in Metabolic and Bariatric Surgery Patients
Informed Consent Form to Participate in Research
Selwan Barbat MD, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this study is to determine if 
laparoscopic TAP block using bupivacaine is equivalent to liposomal bupivacaine in terms of: 
amount of opioids (narcotic pain medications) needed, postoperative nausea and vomiting, and 
patient satisfaction. You are invited to be in this study because you have decided to undergo 
bariatric (weight loss) surgery. It is our standard practice to give local numbing medicine at the 
time of your surgery as a laparoscopic Transversus Abdominus Plane (TAP) Block. Some 
surgeons currently use a medication called liposomal bupivacaine and others use plain 
bupivacaine. We know both medications work well to control postoperative pain, but this is the 
first study to compare them against each other in patients undergoing bariatric surgery.
Participation in this study will involve completing daily surveys sent to you via the Seamless 
MD app on your smartphone. We will also collect data from your medical records pertaining to 
the surgery. This will last approximately 30 days from your surgery. All research studies involve 
some risks. A risk to this study that you should be aware of is some risk of loss of 
confidentiality. We will do all we can to keep your information confidential. It is possible some 
of the items in the survey may make you feel uncomfortable. You may ask to stop participating 
in the study at any time. It is our standard practice to perform laparoscopic TAP block at the time 
of surgery and theoretical risks include bleeding and local anesthetic toxicity. Both of these risks 
are extremely rare and equivalent whether liposomal or plain bupivacaine is used. You may or 
may not benefit from participation in this study.
Your participation in this study is voluntary. You do not have to participate in this study if you 
do not want to. There may be other choices available to you. Some other choices may include 
undergoing your surgeon’s preference of TAP block anesthetic (the usual practice).You will not 
lose any services, benefits, or rights you would normally have if you choose not to participate.
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
study. If you have questions, suggestions, or concerns regarding this study or you want to 
withdraw from the study please contact the Principal Investigator Dr. Selwan Barbat:
 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Wake Forest University 
Health Sciences Research Subject Advocate at 
.
INTRODUCTION
You are invited to be in a research study. Research studies help scientist learn new information 
that may help other people in the future. You are being asked to be in this study because you 
have decided to undergo bariatric (weight loss) surgery. Your participation is voluntary. You do 
not have to be a part of this study if you do not want to. Please take your time in making your 
decision if you would like to join. Ask your study doctor or the study staff to explain any words 
or information contained in this informed consent document that you do not understand. You 
may also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to compare the effects (good and bad) of plain Bupivacaine 
with Liposomal Bupivacaine, which are both used to provide pain relief during and after surgery, 
to see which is better.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
212 patients at one research site (Atrium Health) will be involved in this study. 
You are not allowed to take part in this study if you:

Do not have a smartphone or tablet in which the Seamless MD app can be downloaded

Cannot speak English

Are undergoing revisional bariatric surgery or 

Need another procedure at the time of your bariatric surgery (e.g. hiatal hernia repair or 
ventral hernia repair)

Take opioid pain medication at home
WHAT IS INVOLVED IN THE STUDY?
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


You will be randomized into one of the study groups described below. Randomization means 
that you are put into a group by chance. It is like flipping a coin. You will not know which drug 
you are receiving. This is done so that a fair evaluation of the results can be made. 
If you decide to participate in this study you will be expected to:

Undergo your weight loss surgery as scheduled. Then,

Complete daily surveys sent to you via Seamless MD for 2 weeks postoperatively

Attend your follow-up appointments
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about 30 days after your surgery. You can stop participating at any 
time. If you decide to stop participating in the study, we encourage you to talk to the 
investigators or study staff first. There will be no serious consequences of sudden withdrawal 
from the study. You should feel not feel pressured to be a part of this study. If you decide not to 
be in the study, this will not harm your relations with your doctors or with Atrium Health. You 
are free to stop being in the study if you change your mind after entering it. This would not harm 
your relations with your doctors or Atrium Health.
The researchers may choose to remove you from the study if there is a medical condition, event, 
or situation that makes taking part in this study not in your best interest. 
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Risks and side effects related to the TAP block drugs we are studying 
include: bleeding, local anesthetic toxicity. These are very rare.
Taking part in this research study may involve providing information that you consider 
confidential or private. Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
There also may be other risks that we cannot predict. You should tell the research staff about all 
the medications, vitamins, and supplements you take and any medical conditions you have. This 
may help avoid side effects, interactions, and other risks to your health.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
You are not expected to receive any direct benefit from taking part in this research study. We 
hope the information learned from this study will benefit other people in the future. There is a 
potential you may have less postoperative pain in the Liposomal Bupivacaine group. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study. You should talk to the researchers about all the choices you 
have. Instead of being in this study, you have the option of undergoing your surgery with TAP 
block as usually provided, at your surgeon’s recommendation. You could be treated with 
Bupivacaine or Liposomal Bupivacaine even if you do not take part in the study.
WHAT ARE THE COSTS?
All study costs, including any study products or procedures related directly to the study, will be 
paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your own responsibility. You will not pay extra money to take part in this study.
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals. Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required or permitted by law, or necessary to protect the safety of 
yourself or others.
Your information may be provided to Federal and other regulatory agencies as required. The 
Food and Drug Administration (FDA), for example, may inspect research records and learn your 
identity if this study falls within its jurisdiction.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. law.  This Web site will not include information that can identify you.  At most, the Web 
site will include a summary of the results.  You can search this Web site at any time.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
WHO IS SPONSORING THIS STUDY?
This study is not being sponsored or funded by any company or institution.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any information we collect from you or any information we get from your 
medical records about your health or behaviors is considered Protected Health Information. The 
information we will collect for this research study includes: data pertaining to your surgery, your 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


use of postoperative narcotic pain medication, your experiences with postoperative nausea or 
vomiting, and patient satisfaction.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with the health care 
operations of Atrium Health, Wake Forest University Health Sciences, and their respective 
affiliated entities. 
We will take steps to keep your Protected Health Information private. We will store records of 
your Protected Health Information in a cabinet in a locked office or on a password protected 
computer.
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.
Some of the people, agencies and businesses that may receive and use your health information 
are the study investigators; investigators at other sites who are assisting with the research; central 
laboratories, reading centers or analysis centers; the Institutional Review Board; representatives 
of Wake Forest University Health Sciences and Atrium Health Facilities; representatives from 
government agencies such as the Food and Drug Administration (FDA) or the Office of Human 
Research Protections (OHRP), the Department of Health and Human Services (DHHS) and 
similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations. Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs, 
videotapes, audiotapes or other recorded media which are identify you unless we you’re your 
written authorization.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


You can tell Dr. Selwan Barbat that you want to take away your permission to use and share 
your Protected Health Information at any time by sending a letter to this address:
 
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
If you choose to participate in this study, your medical record at Atrium Health, Wake Forest 
University Health Sciences, or their respective affiliated entities will indicate that you are 
enrolled in a clinical trial. Information about the research and any medications or devices you are 
being given as a participant may also be included in your medical record. Authorization to access 
this part of the medical record will only be available to people who have a need to know this 
information in order to perform their job-related duties. If you are not a patient of these health 
care facilities, a medical record will be created for you anyway to provide access to this 
important information to providers in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this Web site at any time.
Laboratory test results and other clinically relevant medical reports created as a result of your 
participation in the research study may be entered into the computer systems of Atrium Health, 
Wake Forest University Health Sciences, and/or their respective affiliated entities. These results 
and reports will be kept secure in compliance with applicable laws, with permission to access 
this information limited to individuals with proper authority, but who may not be directly 
involved with this research study.
A medical record will be created for all study participants seen on-site and if a medical record 
doesn’t already exist. Information about your participation in the study will be placed in the 
medical record, along with any routine medical test results that were obtained as part of this 
study.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because of a a medical condition, event, or situation that makes taking 
part in this study not in your best interest. Information that identifies you may be removed from 
the data or specimens that are collected as part of this study and could be used for future research 
or shared with others without additional consent.
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Selwan Barbat:
 
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
.
You will be given a copy of this signed consent form.
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form. If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me. I have had a chance to 
ask questions about being in this study and have those questions answered. By signing this 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am 
pm
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ 
am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024


WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083696
Meeting Date Approved 8/31/2023          
Version Valid Until: 8/30/2024