AnovaOS Network Powered Patient Registry

Sponsor
Anova Enterprises, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05013944
Collaborator
(none)
100,000
1
48
2084.8

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
AnovaOS Network Powered Patient Registry
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Outcome Measures

Primary Outcome Measures

  1. 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;

  2. Assess Clinical, Cost and/or Comparative Effectiveness [5 years]

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

  3. 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;

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Anova Enterprises, Inc
ClinicalTrials.gov Identifier:
NCT05013944
Other Study ID Numbers:
  • ANOVA-001-NPPR
First Posted:
Aug 20, 2021
Last Update Posted:
May 16, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anova Enterprises, Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2022