Information and Agreement for Consumer Testing Participants

Thank you for your interest in the consumer preference testing of Regulora.

Regulora is a digital therapeutic software device that has been cleared by the US FDA for the treatment of abdominal pain associated with Irritable Bowel Syndrome (IBS). Regulora is accessed through your mobile device and delivers behavioral therapy through Gut-Directed Hypnotherapy (GDH). The program can be completed at home.

The consumer preference testing version of Regulora has not been cleared by the US FDA or any other international medical device regulatory body. The purpose of this testing is to assess consumer preference. The testing is not for the purpose of determining safety or effectiveness. The consumer preference testing version of Regulora can be accessed through the Lionfish app for Apple or Android devices (see provided instructions).

An IBS diagnosis is required for participation only to ensure that the information collected reflects the consumer preferences of the IBS patient population. As a “Non-significant risk” device, Regulora has been deemed to not present a potential for serious risk to the health, safety, or welfare of a user. During the test we would like you to help us refine and improve Regulora. We will ask the following questions:

Before the first therapy session:

1. What are your feelings about the idea of using hypnotherapy to treat your IBS?
2. What do you expect to get out of this program?

Before the final therapy session:

1. Now that you’ve gone through six sessions, what are your feelings about using hypnotherapy to treat IBS?
2. Do you feel you are getting what you expected out of this program?
3. Would you consider going through the program again in the future to manage your IBS symptoms?
4. What did you like most about the application?
5. What did you like least about the application?
6. Did you receive enough information about hypnotherapy and IBS before getting started?
7. Are there any features that you would recommend?
8. Did you use the Help section?
   1. If so, did it provide you the information you were looking for?
9. Did you have any issues finding or downloading the application?
10. Did you have to call or email for technical assistance to get the application to work?
    1. If so, did this resolve your problem?

As part of the preference testing, you will be using Regulora in parallel with your usual IBS management or treatment. The purpose of this preference test is not to manage or treat your IBS, or to replace your usual IBS management or treatment. The purpose of this testing is to solicit what you like and don’t like about Regulora and to incorporate your feedback into the design of Regulora. Continue to follow all directions from your health care providers.

By clicking the checkbox for this document during the signup process, you agree to assess Regulora and provide your honest feedback by answering the questions above.