Consent Medical Referral - NoxyPure Therapeutic Nanobubbles
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INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A MARKET RESEARCH STUDY

NAME OF SPONSOR COMPANY:          PeriphEX Corp.              

               

STUDY ADMINISTRATOR:                     Disruptive Engagement                              

INTRODUCTION

You are being invited to volunteer in a market research study. You must read and sign this form before you agree to take part in this market research study. This form will give you more information about the market research that is being collected for this study. Please ask as many questions as you need to before you decide if you want to participate. You should not sign this form if you have any concerns or hesitations after reading the following information.

Your provider is not being paid by the sponsor to conduct this market research study.

You must be honest with your provider about your health history to participate in this market research.

PURPOSE OF THE MARKET RESEARCH STUDY

The purpose of this market research study is to collect information about patient perceptions and experiences regarding NoxyPure. NoxyPure is a topically applied nanobubble gel solution used for the treatment of neuropathy as well as sore and tired feet or hands. You are being invited to volunteer because your provider has recommended NoxyPure to you.

During this market research study, you may continue to use your prescribed medication as directed, as your participation will not affect your current medications. The study requires you answer a series of surveys that ask questions regarding your feelings towards NoxyPure and any improvements you may or may not have from the treatment. In addition, your provider may also ask you questions about your NoxyPure experience and collect information regarding prior treatments and any changes you may have.

HOW LONG THE STUDY LASTS AND HOW MANY PEOPLE WILL BE PARTICIPATING

The market research study may last up to 10 weeks and will involve 10 or more short surveys. Approximately 100-150 people are expected to participate in the study.

TO BE IN THIS MARKET RESEARCH STUDY

To be in this market research study you must:

  • Be at least 21 years of age
  • Provide informed consent to participate (to be found further down on this page)
  • Have been recommended NoxyPure by your provider
  • Provide truthful information to your provider

WHAT WILL HAPPEN DURING THE MARKET RESEARCH STUDY

You will be asked to sign this consent form if you wish to volunteer for this market research study. Before beginning the NoxyPure treatments, you will be asked to fill out a pre-treatment online survey that will ask you general questions regarding your diagnosis, current symptoms, medications and treatments. After each treatment, you will fill out a quick online survey that will ask you questions regarding your pain improvement, experience, and satisfaction. Once your treatments are completed, you will be asked to fill out a final online survey regarding the overall satisfaction and experience you have had with NoxyPure. All survey links will be sent to you via email or text.

During the market research study, it is important that you:

  • Use NoxyPure as instructed
  • Are willing and able to follow the market research study directions and procedures
  • Inform your provider about any side effects or problems
  • Ask questions as they arise
  • Tell the market research administrator if you change your mind about staying in the market research study

There are no known or expected risks that come with the completion of this study. If you have questions about potential side effects of NoxyPure, you should discuss them with your provider. If you experience any side effects, you must disclose them with your provider.

POSSIBLE BENEFITS OF THE STUDY

By participating in this market research study, you will receive a limited amount of free treatments and you may discover a new way to alleviate your foot or hand related ailments.

CONFIDENTIALITY

Your records of participating in this market research study will be kept private except when ordered by law. The following people or entities may have access to your market research study records:

  • Your provider
  • Market study administrators
  • PeriphEx Corp (sponsoring and manufacturing company)
  • Certain state or federal regulatory agencies

IN CASE OF STUDY RELATED INJURY

In the unlikely event, you must tell your provider if you feel you have been injured as a result of the market research study procedures.

LEGAL RIGHTS

You will not lose any of your legal rights by signing this consent form.

CONTACT INFORMATION

If you have any questions, concerns, or complaints about this market research study, please contact:

NoxyPure Market Study Administrator

StudyAdministrator@periphex.com

If you require medical attention at any point during this study, please contact your provider or go to the nearest emergency room.

COMPENSATION FOR BEING IN THE MARKET RESEARCH STUDY

Since this is an opt-in, volunteer study, there is no compensation for participating.

VOLUNTEERING TO BE IN THE MARKET RESEARCH STUDY

You are participating in this study at your sole discretion. No one can force you to participate in this study. You may elect to opt-out of this study at any time without penalty.

At any time, the market study administrators, the manufacturing company, or your provider may take you out of the market research study for the following reasons:

  • If you do not follow the administrator’s instructions properly
  • If we find out you are not eligible to be in the market research study
  • If the market research study is stopped
  • If it becomes harmful to your health

If information generated from this market research study is published or presented, your identity will not be revealed. If you leave the study for any reason, the information that you gave up until the point of leaving may be used for research purposes.

NEW FINDINGS

You will be informed should there be any new information or significant findings that would affect your willingness to continue participation in the study.

AGREEMENT TO BE IN THE STUDY

This consent form contains important information to help you understand the requirements and decide if you want to participate in the NoxyPure market research study. If there are any questions or concerns that have not been answered by this consent form, please reach out to the market study administrator at StudyAdministrator@periphex.com.

 
  • I agree to follow the instructions for use of NoxyPure as indicated on the packaging along with reading, understanding, and following the precautions as indicated on the product packaging as listed below -Do not use if there is any open wound or skin breach -Do not microwave -For External Use Only. Do Not ingest -If you observe redness or irritation, stop the treatment and contact your physician -Do not walk during treatment with booties on Feet will be slippery after treatment. Make sure you dry them properly before walking -I also agree I will follow all instructions and precautions as informed by the company and/or study managers

  • IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, YOU SHOULD NOT SIGN THIS CONSENT FORM.

  • Date Format: MM slash DD slash YYYY