Status:
UNKNOWN
ACRODAT Prospective Evaluation Study
Lead Sponsor:
University of Aarhus
Conditions:
Acromegaly
Eligibility:
All Genders
18-99 years
Brief Summary
ACRODAT® is a new software medical device developed by a group of acromegaly experts to help practising endocrinologists assess disease activity in patients with acromegaly. It uses 5 key parameters (...
Detailed Description
This is an international, multicentre, randomised, non-interventional, collaborative post marketing surveillance study to assess the clinical use of the newly developed software medical device named A...
Eligibility Criteria
Inclusion
- All patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve;
- A follow-up visit is scheduled or anticipated for the patient at least once every year;
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of and consented to all pertinent aspects of the study.
Exclusion
- Patients who are surgically cured and remain controlled for at least 3 years;
- Patients who are unable to understand the nature of the study and/or unwilling to sign an informed consent;
- Patients who are unwilling to abide by the guidelines of the study;
- Patients participating in any clinical trial on an investigational medicine or software medical device/evaluation tool for acromegaly.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04349839
Start Date
January 15 2020
End Date
February 1 2025
Last Update
December 4 2023
Active Locations (1)
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1
Århus University Hospital
Aarhus, Denmark, 8200