Frequently asked questions about the Crosstrees System for PVA
What are the risks associated with this procedure?
All surgical procedures carry risks. The risks of the investigational Crosstrees procedure are expected to be no greater than the risks associated with vertebroplasty and kyphoplasty treatments for vertebral compression fractures. These include leakage of bone cement out of the vertebral body; fracture of a spine pedicle or the sternum or ribs; injury to vertebral body endplates; injury to veins, arteries, and nerve tissue of the spine; recurrent disk herniation; spinal fluid leak; and re-operation. Unknown risks associated with the Crosstrees procedure may include the risk of component materials remaining within the body following the procedure.
Why should I participate in the clinical trial?
The primary benefit to you is the potential reduction in risk of cement leakage and the side effects associated with it. Participation in the clinical trial is voluntary and based on your informed consent.
Does it cost anything to participate in the clinical trial?
Participants and/or their insurance carrier are responsible for payment of costs normally incurred in the treatment of the medical condition and surgical procedure. The physician may discuss the estimated cost of the procedure. Costs incurred because of participation in the investigational portion of the study, such as the patient follow-up visits, will be covered by the study sponsor.
System will be provided at no charge.
Will my information be kept confidential?
The handling of medical information obtained in clinical research is governed by national and international data protection regulations and medical confidentiality. Your identity will be kept confidential at all times except to a few employees or subcontractors (monitors and auditors) of Crosstrees Medical who need to check study data and to inspectors of national or foreign regulatory authorities. They will see your name and your medical information but will never disclose your name to anyone else. Your name or anything that could identify you will not appear in any report or record of the study.
What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
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 research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the benefits and risks of participating in a clinical trial?
Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.
Risks
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including
trips to the study site, more treatments, hospital stays or complex dosage requirements.
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Participate in the Clinical Trial
Contact us today to discuss your eligibility for the clinical study of the Crosstrees System™ for Percutaneous Vertebral Augmentation (PVA). This study is registered with ClinicalTrials.gov.
CALL 1-866-442-2328, ext. 818
Request more information:
A clinical trial to evaluate the performance of the Crosstrees System is also being conducted in the European Union in 2009-2010. If you would like more information about the European trial, please send an email to info-eu@crosstreesmedical.com.
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