A study for women who want permanent birth control without surgery
This study will test the safety of the investigational FemBloc Permanent Contraceptive System in preventing pregnancy
Women choose their birth control method for many reasons:
effectiveness, convenience, cost, side effects and whether they plan to have children in the future.
Currently, for women who no longer want children, surgery is the only permanent option. Either tubal ligation (“tying your tubes”) or a hysteroscopy surgery like “Essure®.” Some women who no longer want to have children may be choosing other methods of contraception because they don’t want to have surgery and an alternative simpler permanent solution is not available.
If you're interested in volunteering for this study,
please take the pre-screening questionnaire!
The FemBloc Permanent Contraceptive System consists of two steps:
1) FemBloc treatment is done using a catheter device that is similar to an intrauterine device (IUD).
Instead of placing an IUD, that stays in the uterus, the FemBloc catheter device (called Delivery System)
is placed in the uterus and a small amount of fluid (called Biopolymer) is delivered to each fallopian tube
and then the catheter device is removed. Over time, the fluid causes the tube to react and become blocked
similar to how your skin heals after a cut. The biopolymer is designed to break down over time and leave the body.
2) The natural blocking of your tubes takes several weeks. For 3 months after the procedure, you will
need to use another method of birth control. The second part of the FemBloc System is a confirmation test
using vaginal ultrasound with saline and air to check that your tubes are blocked. This test is done in your
doctor's office.
Study Info
Start Date And Purpose
Currently Enrolling - To test the safety of the FemBloc Permanent Contraceptive System as a method to prevent pregnancy. You will be part of a small study (up to 50 participants) taking place at 5 locations in the U.S.
Who Is Needed
Healthy women of child bearing age who want permanent contraception
Not currently pregnant or attempting pregnancy
Have not had tubal surgery or an ectopic pregnancy
Risks and Benefits will be discussed with volunteers as part of the informed consent process.
Study Duration
The FemBloc treatment procedure usually takes only a few minutes while the entire study procedure visit should take about one hour. The same is true for the 3‐month confirmation test. We will follow you for 5 years after treatment.
Visit includes a urine pregnancy test, testing for Chlamydia and Gonorrhea, pap test if not current, health history, vaginal ultrasound and pelvic exam, and IUD removal if in place.
Procedure & Follow Up
Treatment Visit
Visit includes a urine pregnancy test, the FemBloc treatment procedure followed by a vaginal ultrasound to look at the Biopolymer placement. You need to use another method of birth control until your confirmation test.
E‐diary
You will be asked to keep an e‐diary for six months after the procedure.
7 Day Follow Up After Treatment Visit
You will be called and asked
study-related questions.
3 Month Confirmation Test
Visit includes a urine pregnancy test and a vaginal ultrasound that uses saline and air to confirm
your fallopian tubes are blocked. If blocked,
you will be told to rely on FemBloc as your birth control method.
6 Month Follow Up
Visit includes a urine pregnancy test and you will be asked study-related questions.
1 Year Follow Up
After Confirmation Test
You will be called and asked study-related questions, and you will need to take a urine pregnancy test at home.
18 months, and 2, 3, 4, 5 Years Follow Up After Confirmation Test
You will be called and asked
study-related questions.
Frequently Asked Questions
1. Can I take part in this study? You may be eligible for this study if:
You are a female, 21‐ 45 years of age
You are certain you do not want to get pregnant again and want permanent birth control
You agree to use temporary birth control (excluding IUD) until the test confirms your tubes are blocked. If you are using an IUD now, you agree to have it removed.
You are having sex with a male partner who is not sterile
You are not pregnant at time of screening and procedure visits
You accept the risk of pregnancy during the study
2. Who cannot take part in this study? You cannot join this study if:
You are or may be pregnant
You have had a prior tubal surgery
You have had an ectopic pregnancy
You had a child or terminated a pregnancy in the last 6 weeks
You have unexplained uterine bleeding
You have an abnormal uterus that prevents proper placement of FemBloc
You have an active or untreated pelvic infection
You have gynecologic cancer
You have a compromised immune system
You have hypersensitivity to cyanoacrylate or formaldehyde
3. How long will my FemBloc procedure last?
The FemBloc treatment procedure usually takes only a few minutes while the entire study
procedure visit should take about one hour. The same is true for the 3‐month confirmation
test. We will follow you for 5 years after treatment to continue to evaluate for safety and
effectiveness.
4. Will it cost me anything to be in this study?
There is no cost to you for participating in this study. You will receive compensation for your time to participate in all study visits.
5. Are there possible risks or side effects?
There are always risks of adverse events or side effects related to your participation in this or any study. The doctor or study coordinator will discuss the potential risks and/or side effects in more detail with you during your initial consultation. The biggest risk is that the procedure will not work and you will be at risk of pregnancy.
6. What happens if I choose to join this study?
If you enroll in this study a study coordinator or doctor will discuss study details with you
including: study screening, procedures and short and long term follow up schedule listed
below.
7. What are the benefits of participating in the study?
Taking part in this study may or may not provide you with a permanent contraceptive
solution. The information and knowledge gained from this study could help provide a safe
and effective family planning option for millions of women. Your participation, should you
qualify, will be greatly appreciated and you’ll be part of a community working toward
advancing women’s healthcare by providing better contraceptive options for women
worldwide.
8. What if I no longer want to participate in the study?
You may withdraw your consent at any time, for any reason, and drop out of the study. If
you decide to withdraw, inform the study staff of your decision.
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This pre-screening questionnaire will let you know if you're a potential candidate for the study.
If you are, you'll be asked to submit your contact information to a study coordinator at Chattanooga Medical Research, LLC who will contact you within a few days.
Consent for online screening
Femasys Inc. is funding this research study.
In order to determine if you are eligible for this research study you need to answer a few questions. This is called a pre-screening questionnaire and is for research purposes only. It will last less than 5 minutes. You will be asked some questions about your reproductive health history to ensure you meet requirements to participate in this study. If you qualify, you will be asked to provide your name and phone number so that a member of our study staff can contact you to provide you with additional information and ask more questions.
You will not benefit from participating in the initial pre-screening electronically or by phone. If, after completing this online screening, you are eligible for the research study, you will be asked at a later date to sign a separate consent form that includes more detailed information about the full study.
Though we do everything we can to protect your confidentiality, there is a small risk that the information you share with us by participating in this pre-screening could be accidentally disclosed. We try to minimize this risk by using secure servers for the transmission and storage of information related to this study. When possible, the research team will make sure information cannot be linked to you (de-identified).
Thank you for your time and consideration.
Accept Consent:
I agree to participate in this online screening.
In order to determine if you are eligible for this research study you will need to answer a few questions. This is called a online screening questionnaire. The questionnaire is for research purposes and could last about [ 5 minutes]. You will be asked questions about your reproductive health history to ensure you meet the requirements to participate in this study.
A risk of participating in an online screening questionnaire is that confidential information about you may be accidentally disclosed. You will not benefit from participating in the phone screen.
We will keep the information you provide confidential by using secure servers for the transmission of information. You will need to provide your name and phone number and a member of our study staff will contact you via telephone to provide you additional information and ask more questions. After you are contacted all emails will be destroyed. However, federal regulatory agencies and Washington University, including the Washington University Institutional Review Board (a committee that reviews and approves research studies) and the Human Research Protection Office may inspect and copy records pertaining to this research activity.
Your participation in this screening questionnaire is completely voluntary. You may choose not to take part at all. If you decide to participate in the online screening questionnaire you may stop participating at any time. Any data that was collected as part of this screen will remain as part of the study records and cannot be removed. If you decide not to take part in the screen, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.
If, after completing this online screening questionnaire, you are eligible for the research study you will be asked at a later date to sign a separate consent form that includes more detailed information about the study.
As part of the online screening questionnaire you will be asked questions that will generate Protected Health Information, or PHI. PHI is health information that identifies you and is protected by law under HIPAA (the Health InsurancePortability and Accountability Act). To take part in this online screening questionnaire you must give the research team permission to use and disclose your PHI for this study as explained during the consent process for the screening. The research team will follow state and federal laws and it is possible that other people may become aware of your participation in this screening and may inspect records pertaining to the research. This could include university representatives, to complete university responsibilities and government representatives, (including the Office for Human Research Protections and the Food and Drug Administration) to complete federal or state responsibilities, and Femasys, Inc.
Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA.
The research team will only use and share your information as talked about during this consent process. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed during this consent process. If you have questions or concerns about your privacy and the use of your PHI, please contact the University's Privacy Officer at 866-747-4975.
Although you will not be allowed to see the study information, you may be given access to your health care records by contacting your health care provider.
If you do not agree to allow us to use your PHI it will not affect your treatment or the care given by your health provider, insurance payments or enrollment in any health plans, or any benefits to which you are entitled. However, it will not be possible for you to take part in the study. If you agree, you authorize the use of your PHI for this research, and your authorization will not expire. You may later change your mind and not let the research team use or share your information.
In order to revoke your authorization, you will need to complete a withdrawal letter. Please contact the Human Research Protection Office for more information on how to revoke your authorization or contact the research team to request the withdrawal letter. If you revoke your authorization, the research team may only use and share information already collected for the study. Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons. You will not be allowed to continue to participate in the study.
We encourage you to ask questions. If you have any questions about the research study itself, please contact: Michele Curran at (314) 747-1331. If you have questions, concerns, or complaints about your rights as a research participant, please contact the Human Research Protection Office at 660 South Euclid Avenue, Campus Box 8089, St. Louis, MO 63110, 1-(800)-438-0445 or email hrpo@wusm.wustl.edu. General information about being a research participant can be found on the Human Research Protection Office website. To offer input about your experiences as a research participant or to speak to someone other than the research staff, call the Human Research Protection Office at the number above.
Please check the box in the prescreeing questionaire to indicate that this research study has been explained to you, and you have not additional questions
Questionnaire
This pre-screening questionnaire will let you know if you're a potential candidate for the study.
If you are, you'll be asked to submit your contact information to a study coordinator at Chattanooga Medical Research, LLC who will contact you within a few days.
Project Name
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