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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05013944
Other study ID # ANOVA-001-NPPR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2026

Study information

Verified date January 2024
Source Anova Enterprises, Inc
Contact Christopher Beardmore
Phone +1 (224) 218-2408
Email chris@anovaevidence.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100000
Est. completion date August 31, 2026
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States Anova Enterprises, Inc. Arlington Heights Illinois

Sponsors (1)

Lead Sponsor Collaborator
Anova Enterprises, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess Natural history 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; 5 years
Primary Assess Clinical, Cost and/or Comparative Effectiveness Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment; 5 years
Primary Assess Safety Measuring and monitoring safety and harm associated with the use of specific products and treatments, including conducting comparative evaluation of safety and effectiveness; 5 years
Primary Measuring and/or Improving Quality of Care Measuring or improving quality of care, including conducting programs to measure and/or improve the practice of medicine and/or public health. 5 years
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