AnovaOS Network Powered Patient Registry
Study Details
Study Description
Brief Summary
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in patients with complex disease globally.
Detailed Description
The AnovaOS™ Network Powered Patient Registry may be used to inform the development and conduct of clinical trials and observational studies designed to better understand, prevent, diagnose, treat, ameliorate or cure disease. The AnovaOS™ Network Powered Patient Registry may additionally be used to expedite identification and recruitment of participants for clinical trials of promising therapeutics and observational studies.
Study Design
Outcome Measures
Primary Outcome Measures
- Assess Natural history [5 years]
Assessing natural history, including estimating the magnitude of a problem; determining the underlying incidence or prevalence rate of a condition; examining trends of disease over time; assessing service delivery and identifying groups at high risk; and describing and estimating survival;
- Assess Clinical, Cost and/or Comparative Effectiveness [5 years]
Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;
- Assess Safety [5 years]
Measuring and monitoring safety and harm associated with the use of specific products and treatments, including conducting comparative evaluation of safety and effectiveness;
- Measuring and/or Improving Quality of Care [5 years]
Measuring or improving quality of care, including conducting programs to measure and/or improve the practice of medicine and/or public health.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old or older;
-
Confirmed positive diagnosis of disease, condition or disorder. This will be self-reported or reported by the patient's provider, advocacy group or other patient representative;
-
Laboratory or other independent means of confirmation is not required but may be confirmed in clinical trials;
-
Able to understand and willing to sign the informed consent document; or whose legal representative has given consent to participate in the research per state and Federal requirements;
-
Willing and able to complete the registry questions or have the instrument(s) completed by an informed proxy;
-
Anticipated additional follow up with the registry once per year.
Exclusion Criteria:
-
Subjects who do not meet the inclusion criteria for the study;
-
Subjects who are unable to understand the protocol or unable to provide legally effective informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Anova Enterprises, Inc. | Arlington Heights | Illinois | United States | 60005 |
Sponsors and Collaborators
- Anova Enterprises, Inc
Investigators
- Study Director: Martin Walsh, Anova Enterprises, Inc
- Principal Investigator: Christopher Beardmore, Anova Enterprises, Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ANOVA-001-NPPR