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frequently asked questions

Below are answers to some commonly asked questions about the RESOLVE II Study.

Q: Who can participate in this study?

Q: Has this sinus product been studied in humans before?

Q: What are possible risks and discomforts?

Q: I am interested in hearing more. What is the next step?

Q: What will I have to do if I decide to participate in the study?

Q: What are the benefits of participating in the study?

Q: Will I be paid if I take part in this study?

Q: Can I voluntarily withdraw from the study?

Q: Who will pay for the procedure?

Who can participate in this study?

If your symptoms of nasal blockage have returned after sinus surgery, you might be eligible to participate in this study. To determine the intensity of your symptoms, you will be asked to complete a daily diary via phone for 14 days. For more information, please click the “Eligible Patients” tab above or contact a clinical study site near you.

The study is designed to enroll 300 patients altogether in this study at up to 45 sites across the United States. Participants will be in the studied for 3 months after the product placement.

Has this sinus product been studied in humans before?

The investigational, steroid-eluting product has been evaluated in 3 studies with 117 patients. The purpose of the RESOLVE II Study is to test the product in a larger group of patients.

What are possible risks and discomforts?

Like all clinical research studies, there are some risks associated with the RESOLVE II Study. Please contact the clinical study site near you to learn more about the possible risks and discomforts.

I am interested in hearing more. What is the next step?

To get connected with the local RESOLVE II Study center in your area, the next step is taking the pre-screening questionnaire. The questionnaire will help determine if you meet some of the main criteria for the study. If the pre-screening questionnaire indicates you qualify, you will be given the option to have your contact information sent directly to the local RESOLVE II Study center in your area. Someone from your local study center will then contact you within a couple of days to tell you more about the study, and help you decide whether you would like to participate. Please click here to find out how to take the pre-screening questionnaire.

What will I have to do if I decide to participate in the study?

After you agree to participate in the study and sign the informed consent form, you will undergo the following screening procedures to determine if you are eligible for the study:

Interview by the study doctor
Complete symptom questionnaires
Complete a daily diary for 14 days
Undergo an endoscopy to determine the current status of your sinuses
Give urine for a pregnancy test, if you are female of child bearing age

What are the benefits of participating in the study?

As participants in this study, the patients are partners in research and play an important role in advancing the treatment choices for chronic sinusitis.

By taking part in the RESOLVE II study, you can try this new chronic sinusitis treatment, which may or may not be better than the treatment options that already exist to help your condition. While no benefit is guaranteed, it is possible that your sinus condition may get better. While it is also possible that your condition may remain unchanged or get worse, we hope the information learned from this research study will benefit other individuals with recurrent sinus obstruction in the future. The participants in this study will help the researchers to learn more on the treatment options for of chronic sinus disease.

Will I be paid if I take part in this research study?

Patients will be compensated for their time and travel associated with their participation in the study.

Can I voluntarily withdraw from the study?

Taking part in this study is voluntary. You can withdraw your consent or discontinue participation in this study at any time. Your decision to leave the study will not cause any penalty or loss of benefits to which you are entitled.

Who will pay for the procedure?

All study related costs will be covered by the Sponsor of the study. The company responsible for this study is Intersect ENT, headquartered in Menlo Park, California. To learn more about the company, please visit www.intersectent.com