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Recruiting

NCT Number: NCT05013944

AnovaOS Network Powered Patient Registry

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.

Recruiting

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Key information

Conditions

Infectious Disease Certain Conditions Originating in the Perinatal Period Chemically-Induced Disorders Chromosome Aberrations Communicable Diseases Congenital Abnormalities Congenital Malformations, Deformations and Chromosomal Abnormalities (Q00-Q99) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89) Diseases of the Circulatory System Diseases of the Digestive System Diseases of the Ear and Mastoid Process Diseases of the Eye and Adnexa Diseases of the Genitourinary System Diseases of the Musculoskeletal System and Connective Tissue Diseases of the Nervous System Diseases of the Respiratory System Diseases of the Skin and Subcutaneous Tissue Ear Diseases Endocrine, Nutritional and Metabolic Diseases (E00-E89) External Causes of Morbidity and Mortality Eye Diseases Factors Influencing Health Status and Contact With Health Services Infections Injury, Poisoning and Certain Other Consequences of External Causes Mental Disorders Mental and Behavioural Disorders Metabolic Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Pregnancy, Childbirth and the Puerperium Respiration Disorders Respiratory Tract Diseases Skin Diseases Skin and Connective Tissue Diseases Symptoms, Signs and Abnormal Clinical and Laboratory Findings, Not Elsewhere Classified Urogenital Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anova Enterprises, Inc.

Arlington Heights, Illinois, 60005, United States

Location status: Recruiting

Location contact

Christopher Beardmore

PRINCIPAL_INVESTIGATOR

Martin Walsh

CONTACT

[email protected]

224-218-2408

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assess Natural history

    Time frame: 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;

  2. Assess Clinical, Cost and/or Comparative Effectiveness

    Time frame: 5 years

    Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;

  3. Assess Safety

    Time frame: 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;

  4. Measuring and/or Improving Quality of Care

    Time frame: 5 years

    Measuring or improving quality of care, including conducting programs to measure and/or improve the practice of medicine and/or public health.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Beardmore

CONTACT

[email protected]

+1 (224) 218-2408

Sponsors and collaborators

Lead sponsor

Anova Enterprises, Inc

Industry

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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