Solace AttenueX Balloon
Study Details

To learn more about participation in this clinical study, click here or phone our Bladder Study Center toll-free at 1-877-52-STUDY (527-8839) to see if you qualify.

The Bladder Study Center will be able to assess your initial eligibility for study participation and refer you to a study center in your area if you qualify.

Frequent Questions

What is the purpose of a clinical trial?

The purpose of a clinical trial or study is to examine new treatment options for specific health conditions. The Food and Drug Administration (FDA) requires clinical research trials before it can approve a new treatment as safe and effective for general use. A clinical trial shows how an investigational treatment affects patients with specific health conditions and whether or not it is better than the current standards of care.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new experimental treatments before they are widely available, and help others by contributing to medical research.

What happens during a clinical trial?

The process for a given clinical trial depends on the type and design (protocol) of the trial being conducted. The clinical trial team usually includes doctors, nurses and other healthcare professionals. This team will check the general health of the participant at the beginning of the trial, focus specifically on the disorder under investigation, provide specific instructions for participating in the trial, deliver the treatment under study, monitor the participant carefully during the trial and stay in touch after the trial is completed. Most clinical trials involve more information collection and office visits than the participant would normally have for a given disorder. Clinical trial outcomes are most successful when the protocol is carefully followed. The research staff will speak to the participant regarding the importance of following the prescribed protocol.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol (a plan that details what researchers will do in the study). As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

How is the confidentiality of the participant protected?

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was developed by Congress to protect the confidentiality of a person's medical information. It sets boundaries on the use and release of health records and establishes safeguards to protect the privacy of health information.

What are the costs involved with the Solace Balloon trial?

All study-related medical care in the Solace Balloon trial is provided at no cost to the patient.
To see if you qualify for this clinical study, please call toll-free 1-877-52-STUDY (527-8839). The Bladder Study Center will be able to assess your initial eligibility for study participation and refer you to a study center in your area if you qualify.