AnovaOS Network Powered Patient Registry

Recruiting

• Conditions: Diseases of the Genitourinary System; Endocrine, Nutritional and Metabolic Diseases (E00-E89); Pregnancy, Childbirth and the Puerperium; Congenital Malformations, Deformations and Chromosomal Abnormalities (Q00-Q99); Injury, Poisoning and Certain Other Consequences of External Causes; Diseases of the Nervous System; Diseases of the Digestive System; Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89); Mental and Behavioural Disorders; Diseases of the Eye and Adnexa

• Registration Number: NCT05013944
• Lead Sponsor: Anova Enterprises, Inc

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 Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-20
• Study Start: 2021-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess Clinical, Cost and/or Comparative Effectiveness	5 years	Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;
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;
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.
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;

Trial Locations

Locations (1)

Anova Enterprises, Inc.; 🇺🇸 Arlington Heights, Illinois, United States