Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
Phase: NA
Conditions: Contraception
Sponsor: Wright State University

Essure HyCoSy Ultrasound Grant Application 
 
Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the 
Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using 
EssureTM? 
 
 
Revision 2; Version date: 04/19/2016 
 
 
 
Steven R. Lindheim M.D., MMM Tom Winter, MD, and Jerome Yaklic, MD 
 
 
NCT02628873 
 
 
 
Hypothesis:  
We hypothesize that performing saline infused sonography (SIS) with directed air bubbles for 
hysterosalpingo-contrast sonography (HyCoSy) is at least as equivalent or superior in evaluation 
of fallopian tube patency following hysteroscopic EssureTM  tubal sterilization in those undergoing 
X-ray hysterosalpingography (HSG).  We also hypothesize that performing HyCoSy with air 
bubbles is more cost-effective and less painful than HSG.   
 
Objectives:  
 
Currently, in the USA, Essure is approved by the Food and Drug Administration (FDA) for 
hysteroscopic sterilization (1). The effectiveness of permanent sterilization  is 99.8%, with successful 
bilateral placement rate for each delivery system approximately 96.5% (1,2). Current FDA labeling 
for Essure requires an HSG 3 months after placement to confirm the proper coil position and tubal 
occlusion (1). However, HSG is not the ideal confirmatory test given the following inherent issues (3-
5):  
 
1. Exposure to ionizing radiation 
2. Cost 
3. Patient discomfort  
4. Inconvenience 
5. Poor inter-observer reproducibility  
6. Variability in the technique 
7. Tubal spasm potentially creating the false impression of proximal tubal occlusion 
 
In fact, 30% of unintended pregnancies after hysteroscopic tubal occlusion placement have been 
attributed to misinterpretation of the HSG (6).  Thus, our primary objective is to determine if HyCoSy 
with air bubbles is equivalent to HSG in the diagnosis of tubal patency in patients undergoing 
hysteroscopic sterilization using EssureTM.  Secondary objectives include 1) Pain assessment of each 

procedure and 2) Cost analysis. To address these objectives we propose the following specific aims: 
 
 Primary Specific Aims:  
 
1. To demonstrate an equivalent or superior evaluation of fallopian patency by HyCoSy using 
air-bubbles in comparison to HSG.   
 
Secondary Specific Aims:  
 
1. To compare pain scores in those undergoing SIS/HyCoSy to HSG in order to assess overall 
tolerability of SIS/HyCoSy. 
2. To compare assessment of the uterine cavity using SIS air-bubble contrast using SIS-
catheter in comparison to HSG.   
 
 
Background and Significance: 
 
Tubal disease accounts for 30 to 40% of all cases of infertility (7,8).  The gold standard for tubal 
evaluation is laparoscopy with dye (chromopertubation).  The standard non-operative method for 
evaluating pelvic anatomy has been the HSG (9-11).  The HSG, however, requires exposure to 
ionizing radiation and the need for iodinated contrast material.  Proper technique in performing an 
HSG is imperative since inadequate uterine distension may result in poor visualization or 
overzealous instillation may easily obscure uterine pathology or cause inadvertent tubal spasm 
suggesting pathology (4, 7-11).   In contrast, the use of sonography combined with intrauterine 
saline instillation, termed SIS, has become routine for evaluation of intrauterine cavity pathology 
and has been shown to have similar predictive value to hysteroscopy (12-15).   
A number of clinical trials have suggested SIS application in fallopian tube assessment for 
infertility (16-48). Contrast agents that have been described include the use of a suspension of 
galactose micro-particle granules (Echovist-200), perflutren lipid microspheres (Definity), and 
air bubbles to enhance contrast in the fallopian tubes (sonosalpingography-SSG or 
hysterosalpingo-contrast sonography-HyCoSy).  Each has been reported to have similar diagnostic 
accuracy as HSG with iodinated contrast material (17-21).  Furthermore, there are added 
advantages of minimizing risks (i.e. no ionizing radiation), better 3-dimensional imaging of the 
uterus and allowing for the evaluation of tubal and ovarian pathology during the same study.  
Disadvantages of its use include false positive results of tubal occlusion related to tubal spasm, 
difficulty assessing fallopian tubes with abnormal anatomy and interference of echogenicity from 
over-lying bowel.  Additionally, only one tube can be visualized at a time, therefore it is possible 
to miss flow through the contralateral tube with initial injection.  
Specifically, studies using Echovist-200 (developed for cardiac ultrasound) demonstrated 83% 
agreement with HyCoSy compared to laparoscopy, compared to a 76% agreement with HSG and 
laparoscopy (22,42, 49-52). The contrast material, however, is very expensive (>$500), obviating 
its routine use in the office setting. The use of perflutren lipid microspheres (Definity) in cardiac 
imaging has allowed for stability of the contrast media (50-52).  Recent studies using Definity 
microspheres have been described for its use with HyCoSy to assess tubal occlusion after Essure 
Tubal Sterilization, which demonstrated 100% agreement with HSG in assessing tubal patency 

and 82% agreement with respect to tubal occlusion. Moreover, patients preferred undergoing 
HyCoSy in the comfort of the gynecology office rather than the radiology department (50). As 
such, while Definity  appears to be a safe and effective contrast media for HyCoSy, however, 
this contrast is not FDA approved and further studies are needed to determine its diagnostic 
accuracy and reproducibility. 
A substituted a mixture of saline and air for distending media has also been described (16, 40–
43) where some vigorously shake a syringe of saline and air creating air bubbles immediately 
before infusion, while others have described filling a syringe with both air and saline and tilting 
the syringe with the intermittent infusion of air followed by saline in increments of 1–3 mL 
(38,39, 53-55). Positive and negative predictive values for air contrast HyCoSy appears to be 
similar to other contrast materials for both tubal patency and occlusion when compared to both 
laparoscopy and HSG (38,55). However, as air bubbles disappear quickly, tubal assessment is 
limited. This method  has been shown to have excellent predictive value (80%–87%) when 
compared to laparoscopy. 
 
Recently, an FDA approved device, Femvue ™ Saline-Air Device, creates and delivers a 
consistent alternating pattern of saline and filtered air as a continuous stream in a controlled 
fashion allowing for fallopian tube evaluation under ultrasound guidance (56). Our objective is  
to determine if saline infused sonogram (SIS)-HyCoSy with Femvue ™ Saline-Air Device is 
equivalent or superior to HSG in evaluation of fallopian tube occlusion in those 
undergoing HSG following Essure hysteroscopic tubal occlusion as Comparative studies to 
HSG, are lacking.   
 
The advantages of HyCoSy revolve around its applicability in the office, its cost effectiveness and 
the avoidance of radiation exposure. Although shown to be a practical procedure with 
investigations yielding high accuracy results for both tubal patency and tubal occlusion, as 
mentioned previously, studies are still needed to evaluate this subject matter further. Minimal data 
exist directly comparing HSG versus HyCoSy with air bubble contrast media ss the confirmatory 
test for post hysteroscopic tubal occlusion. We propose to determine the predictive value and 
possible overall superiority of HyCoSy to HSG from a time  effective and pain scale model.  
 
Experimental Design: 
 
 
Thirty-six women who are undergoing post-Essure tubal occlusion evaluation will be invited to 
participate in this study.  Subjects will be recruited and screened from the practice of Wright State 
OB-GYN Physicians.   
 
Inclusion Criteria   
 
1. Documentation of normal PAP smear within one year prior to subject enrollment in study.  
2. Written consent to this study must be given voluntarily. 
3. Need for evaluation of tubal status for  post-Essure tubal occlusion.   
4. Negative urine pregnancy test. 

 
 Exclusion Criteria  
 
1. 
Any prior endometrial ablation procedures or plans to undergo endometrial ablation 
procedures prior to the Essure confirmation test. 
2.         History of unresolved dysfunctional uterine bleeding (DUB). 
3. 
History of a hysterectomy. 
4. 
Current urogenital disease. 
5. 
History of allergic response to IVP dye (exclusion for HSG). 
6.         Abnormal pap smear.  
7.  
Positive urine pregnancy test. 
 
 
Procedure   
 
As part of their post-Essure Tubal occlusion assessment, both air bubble HyCoSy and HSG will 
be performed at the same visit. Patients will undergo air bubble HyCoSy first, performed in the 
office setting, followed by HSG, which will be performed in the radiologic suite Miami Valley 
Hospital. A Likert Pain Scale will be completed prior to testing and at completion of the study for 
each procedure (See below). 
 
1. Saline Infused Sonography (SIS):  
 
SIS will be performed either during the follicular phase of a spontaneous menstrual cycle or 
following a progestin withdrawal bleed.  All patients will be asked to take NSAIDs one hour prior 
to the procedure. A 2-mm lumen SIS balloon catheter will be placed transcervically during a 
speculum examination, with the balloon distended in the lower uterine segment or cervical canal.   
Routine transvaginal sonography of the endometrium, myometrium, and adnexae will be initially 
performed, followed by instillation of 5-10ml of sterile saline through the catheter for uterine 
evaluation.   Transvaginal sonographic images of the sagittal and coronal views of the pelvis will 
be recorded with still images and video.  
 
2. Hysterosalpingo-Contrast Sonography (Air Contrast HyCoSy):  
This will be a randomized prospective trial, where patient will be randomly allocated initially to 
either the Air Contrast HyCoSy or the Hysterosalpingogram.  At least one hour between 
procedures will be required. 
 
 
Air-Contrast HyCoSy 
 
After completion of the SIS evaluation of the uterine cavity, Air Contrast HyCoSy contrast will 
then be performed through the same catheter under direct ultrasound visualization The FemVue™ 
Saline-Air Device will be used for the air contrast HyCoSy.  It is an FDA approved diagnostic tool 
used with SIS to evaluate the intrauterine cavity. The device is applied to the SIS catheter so that 
when filled, is an alternating mixture of air and saline that will be infused into the uterine cavity 
acting as a contrast agent for HyCoSy.  

 
If fallopian tube patency is indeterminate, the patient will be repositioned into a lateral position at 
approximately 45 in order to better visualize the fallopian tube as previously described (17). The 
SIS catheter will be removed at completion of the HyCoSy procedure.  Each patient will complete 
a pain and comfort survey using a Likert Scale questionnaire prior to and following the SIS and 
HyCoSy procedure (See Below). After completion of this survey, the patient will be directed to 
the radiology suite for their HSG. 
 
 
3. Hysterosalpingography (HSG): 
 
Similarly, an H/S catheter will be placed transcervically during a speculum examination, with the 
balloon distended in the lower uterine segment or cervical canal.  Isovue 250 (iodine containing 
radiopaque contrast agent) contrast material will be instilled through the lumen catheter for 
evaluation of the uterine cavity and for fallopian tubal patency under X-ray visualization.  
Instillation of contrast will be performed and tubal patency evaluated with X-ray.  
 
If fallopian tube patency is indeterminate, the patient will be repositioned into a lateral position at 
approximately 45 in order to better visualize the fallopian tube (17). The H/S catheter will be 
removed at the completion of the HSG.  Each patient will complete a pain and comfort survey 
using the Likert Scale questionnaire prior to and following the HSG procedure (See Below).  
 
Women will be randomized to receive the study procedures in one of two orders. Half of the 
women will be assigned to receive the SIS-Air HyCoSy first, followed by the HSG while the 
remaining half of women will receive the HSG first, followed by the SIS-Air HyCoSy. 
 
4. Likert Pain Scale (Appendix A)   
 
 
 
5. Further Testing 
 
If tubal patency is suspected, further diagnostic and treatment options will be discussed, per 
standard of care by their primary physician.   Any further diagnostic and treatment data obtained 
after any other uterine and/or tubal evaluation including hysteroscopy or laparoscopy will be 
collected for comparison to SIS, HyCoSy, and HSG evaluation. A pain scale and time assessment 
of each diagnostic arm will be performed and all subsequent testing and treatment will be 
documented. 
 
 
Radiologic Interpretation: 
 
Each SIS, HyCoSy, and HSG will have printed still and video images recorded on CD for review 
of the diagnostic findings. Images will be labeled with a study number that is distinct for each 
procedure and de-identified of all patient data. A reproductive endocrinologist (SRL) and a 

radiologist (TW) will review all images and video recordings and correlate study interpretation.  
 
Compensation and Cost to Subject: 
 
Subjects will be responsible for the Essure hysteroscopic sterilization.  The study will cover all 
charges related to the cost of the SIS and HyCoSy and HSG. Subjects will be given $50 for their 
inconvenience and for participating in the study. 
 
Statistics: 
 
This will be a randomized prospective clinical trial, where patients will be randomly allocated to 
the Air Contrast HyCoSy or HSG initially followed by the other test with at least 1 hour between 
procedures.  The primary outcome of interest is the agreement between the HSG and air-bubble 
HyCoSy in evaluating tubal patency.  For this purpose the HSG will indicate either tubal patency 
or non-patency and will be considered as the gold standard, and the air-bubble HyCoSy will 
indicate either patency, non-patency, or inconclusive and compared to the gold standard HSG.  
Agreement between the evaluations will be measured using the kappa (κ) statistic. To detect a 
difference in kappa (a correlation) as small as 95% vs 99% you will need 36 with a 20% non-
compliance rate.  This means that you will be able to detect a difference as small as 95-99 OR 
anything larger.  This translates into the assumption that even a 95% kappa is acceptable enough 
to call the methods ‘the same.’ 
 

       Appendix A. Likert Pain Score 
                                                          
 
 
 
  
SIS-SSI 
HSG 
Consent  
  
  
Baseline Pain 
  
  
Pain with Balloon  Placement  
  
  
SIS Findings 
  
N/A 
SIS Volume  
  
N/A 
Time to Complete SIS 
  
N/A 
Pain after SIS 
  
N/A 
SSI Findings 
  
N/A 
Time for SSI Completion  
  
N/A 
SSI Volume 
  
N/A 
Pain after SSI or HSG 
 
  
Cavity Findings on HSG 
N/A 
  
Tube Findings on HSG  
N/A 
  
HSG Volume  
N/A 
  
Time for HSG 
N/A 
  
Preferred Test  
  
  
Reasons: 
  
  

 
 

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Informed Consent 
 
 
 
INFORMED CONSENT AND RESEARCH AUTHORIZATION  
 
Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram  
as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic  
Sterilization Using EssureTM? 
 
Investigator(s): 
Steven Lindheim, MD and Jerome Yaklic, MD 
 
 
 
Department of Obstetrics and Gynecology 
 
Institution: 
 
Wright State University & Premier Health  
Clinical Trials Research Alliance 
 
Sponsor:  
 
Bayer Healthcare Investigator-Sponsored Grant Program 
 
Site(s): 
 
Miami Valley Hospital 
 
Phone number for subjects to call for questions: 937-208-2079 
 
 
Introduction and Background Information 
 
 
You have been asked to participate in a medical research study because you have had your 
tubes “tied” with the EssureTM device. 
Purpose 
 
 
The purpose of the study is to evaluate the use of air bubbles (“Air Contrast”) and an 
ultrasound (hysterosalpingo-contrast sonography or “HyCoSy”) as compared to the standard X-
ray hysterosalpingography (HSG) in evaluation of tubal closure with EssureTM.  HSG is an x-ray 
performed after injecting dye.   
 
We aim to determine if HyCoSy with air bubbles is equal or superior to HSG as well as 
less painful than HSG. Neither one of these procedures is considered experimental. 
 
A transvaginal ultrasound will be used in this study. It will be done as part of the procedure 
for infusing air bubbles into your uterus and fallopian tubes. The doctor will infuse saline into 
your uterus and fallopian tubes, then using the air bubbles device, he will infuse air into your 
fallopian tubes. He will use the ultrasound to watch the bubbles move through your fallopian tubes 
to see if your tubes are open. 
Procedures 
 
Your participation in this study will last for 1 day.  If you consent to participate, you will have the 

following procedures while you are in this study: 
 
1. 
You will be asked to participate and sign this consent form. 
 
2. 
The researchers will gather information about you either directly or by reviewing your 
medical records. This information will be used to decide if you are eligible for the study. The 
following information will be used and/or disclosed for this research study: age, BMI, number of 
pregnancies and treatment outcome data. 
 
3. 
You will be asked to complete a Likert Pain Scale survey about your pain during each 
procedure.  
 
4. 
You will be randomized (like the flip of a coin) to either undergo the SIS-Air-Contrast 
HyCoSy or HSG first followed by the other test within 1 to 2 hours. Subjects will be randomized 
to receive the study procedures in one of two orders. Half of the women will be assigned to receive 
the SIS-Air HyCoSy first, followed by the HSG while the remaining half of women will receive 
the HSG first, followed by the SIS-Air HyCoSy. 
 
Air Contrast HyCoSy Group 
 
For the ultrasound with air bubbles you will be asked to take over-the-counter pain reliever (such 
as ibuprofen) one hour prior to the procedure to minimize cramping. A speculum will be placed 
in the vagina, then a small catheter (smaller than a straw) will be inserted through the cervix and 
a small balloon inflated at the top of the cervix or lower portion of the uterus. The speculum will 
be removed and a transvaginal ultrasound probe with then be placed in the vagina.  Through the 
catheter, sterile saline will be injected into the uterus to evaluate for any abnormalities within the 
uterine cavity. Ultrasound images will be recorded with images and video. After completing the 
evaluation of the uterine cavity, Air-Contrast HyCoSy will then be performed through the same 
catheter. A mixture of saline and filtered air will be introduced under direct ultrasound 
visualization using a FDA approved device called the FemVue™ Saline-Air Device. This mixture 
creates bubbles that can be seen with the ultrasound and will assess if the fallopian tubes are 
closed.  
 
X-Ray HSG Group 
 
For the x-ray HSG, again a speculum will also be placed in the vagina, then a similar small catheter 
will be inserted through the cervix and a small balloon inflated at the top of the cervix or lower 
portion of the uterus. Isovue 250 (iodine containing dye) will be injected and an X-ray will be 
taken to evaluate the uterine cavity and if the fallopian tubes are blocked. If the test is 
indeterminate, you will be repositioned to lie on your side.  
 
 
 

Both Groups 
If it is suspected that your fallopian tubes have not closed, your primary physician will discuss 
further testing and treatment. If you agree, any further testing or treatment data will be collected 
for comparison to the tests above.  
  
Potential Risks 
 
There are inherent risks associated with HSG, which will have been discussed with you by your 
doctor. Specific to this study, the air-contrast HyCoSy carries the risk of cramping, infection and 
bleeding. Risks will be minimized by using sterile technique and standard monitoring during the 
procedure.  
 
There is a risk of loss of confidentiality. Replacing your name with a code and keeping the 
information on a secure server only accessibly to study personnel will minimize this risk. In 
addition, you may suffer harms that we have not seen before.  
 
 
Benefits 
 
There will be no direct benefit to you from participating in this study. However, it is hoped that 
the information gained from the study will help find an alternative to determine that a woman’s 
tubes have been successfully “tied.” 
 
Alternatives 
 
If you choose not to participate in this study, your HSG will be performed in the usual fashion. 
 
Research Related Injury  
 
If you are injured by being in this research study, the investigator will arrange for you to get 
medical treatment.   Wright State University, the study site, nor the investigator has set aside 
money to pay for treatment of any injury.  You and your insurance will be billed for the treatment 
of these injuries.  Before you agree to take part in this research study you should find out whether 
your insurance will cover an injury in this kind of research. You should talk to the investigator or 
staff about this. If you are injured, there is no money set aside for lost wages, discomfort, 
disability, etc.  You do not give up your legal rights by signing this form.  If you think you have 
a research related injury, please call Dr. Lindheim or Dr. Yaklic at 937-208-2079. 
 
Compensation 
 
You will be given a debit card with a MasterCard logo. The card will be loaded with $50 after the 
study visit is completed. This process takes approximately 24 hours, so you may not receive your 
payment immediately. You can also set up a PIN number with the card issuer so that you can use 

the card at any ATM. However, please be aware that ATMs usually charge a fee to use their 
machine. In order for you to receive payment, Greenphire, the issuer of the ClinCard, will be 
provided with your social security number and other demographic information for tax related 
purposes. 
 
 
Costs  
 
The SIS-Air Contract HyCoSy and the HSG are being provided by the study. There will be no 
cost to you for participating in this study. 
 
 
HIPAA Research Authorization  
 
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal 
safeguards for your protected health information (PHI).   Examples of PHI are your name, address, 
and birth date together with your health information.  PHI may also include your medical history, 
results of health exams and lab tests, drugs taken and results of this research study.  Your PHI 
may not be used or shared without your agreement, unless it meets one of the HIPAA exceptions.  
 
State and federal privacy laws protect your health information.  In most cases, health information 
that identifies you can be used or shared by the research team only if you give your permission by 
signing this form.    
 
If you sign this form your health information will be used and shared to answer the research 
questions described above and to make sure that the research was done correctly. The time period 
when information can be used or shared ends when all activities related to this study are 
completed.   
 
Your access to your health information will not be limited during this study. 
 
You do not have to sign this form.  If you do not sign this form you may not participate in the 
study and health information that identifies you will not be shared with the research team.   
 
In our research, the research team will look at and may share information about you and your 
health.  Federal law requires that health care providers and researchers protect the privacy and 
security of health information that identifies you.  We may ask for your health information from 
your primary care physician. 
 
 
 
 
Revocation of Research Authorization 

 
You may cancel the permission you have given us to use and share your protected health 
information at any time.  This means you can tell us to stop using and sharing your protected 
health information.  If you cancel your permission: 
 
• 
We will stop collecting information about you. 
• 
You may not withdraw information that we had before you told us to stop. 
o 
We may already have used it or shared it. 
o 
We may need it to complete the research. 
• 
Staff may ask your permission to follow-up with you if there is a medical reason to do so. 
 
You may cancel your permission by writing to the investigator at the address on page one. 
 
Information Available on ClinicalTrials.gov  
 
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 website at any time. 
 
Confidentiality 
 
Total privacy cannot be guaranteed.  We will protect your privacy to the extent permitted by law.  
If the results from this study are published, your name will not be made public. Once your 
information leaves our institution, we cannot promise that others will keep it private.  Your 
information may be shared with the following: 
 
• 
The sponsor, Bayer Healthcare 
• 
The Wright State IRB and Office of Research and Sponsored Programs   
• 
The local research team 
• 
People responsible for billing, sending and receiving payments related to your participation 
in the study  
 
• 
Greenphire, the issuer of the MasterCard for subject payment 
• 
People who are responsible for research and HIPAA oversight at the institutions where the 
study is conducted  
• 
Government agencies, such as:  
o 
Office for Human Research Protections (OHRP),  
o 
Food and Drug Administration, and 
o 
Office of Civil Rights  
 
Data Security  
 
Your name will be replaced with a code and kept on a secure server only accessibly to study 

personnel. 
 
Conflict of Interest  
 
This study may involve a conflict of interest because the institution will be compensated for your 
participation in it through a grant provided by Bayer Healthcare.  The institution will then pay the 
investigator for the research procedures he performs during your participation. Please ask the 
investigator how the institution and/or investigator will benefit by your participation in the study. 
 
Voluntary Participation 
 
Taking part in this study is completely voluntary. You may choose not to take part at all.  If you 
decide not to be in this study, you won’t be penalized or lose any benefits for which you qualify. 
If you decide to be in this study, you may change your mind and stop taking part at any time. If 
you decide to stop taking part, you won’t be penalized or lose any benefits for which you qualify.  
You will be told about any new information learned during the study that could affect your 
decision to continue in the study. 
 
Termination  
 
The investigator, the IRB or the study sponsor has the right to stop this study at any point.  The 
investigator may take you out of this study with or without your permission.   
 
Participation in Other Research Studies 
 
You may not take part in this study if you are currently in another research study.  It is important 
to let the investigator know if you are in another research study. 
 
Research Subject’s Rights, Questions, Concerns, and Complaints 
 
If you have any questions, concerns, or complaints about the research study you may contact Dr. 
Lindheim at 937-208-2079.   
 
If you have any questions about your rights as a study subject, questions, concerns or complaints, 
you may call the Wright State IRB Office (937) 775-4462.  You may discuss any questions about 
your rights as a subject with a member of the IRB or staff.  The IRB is an independent committee 
composed of members of the University community, staff of the institutions, as well as lay 
members of the community not connected with these institutions.  The IRB has reviewed this 
study.  
   
 
Acknowledgment and Signatures 
 

This form tells you what will happen during the study if you choose to take part.  Your signature 
means that this study has been discussed with you, that your questions have been answered, and 
that you will take part in the study.  This informed consent document is not a contract.  You are 
not giving up any legal rights by signing this informed consent document.  You will be given a 
signed copy of this consent to keep for your records. 
 
____________________________   
Printed Subject Name 
 
 
___________________________________________  
_____________________ 
Signature of Subject  
 
 
 
 
Date Signed 
 
 
 
___________________________________________        
__________________ 
Signature of Person Obtaining Consent   
 
      
Date Signed