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Completed
NCT04349839
ACRODAT Prospective Evaluation Study
Conditions: Acromegaly
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: University of Aarhus
Location: Århus University Hospital Aarhus Århus
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 (IGF-I level, tumour status, comorbidities, symptoms and Quality of life) to evaluate the patient's health status. The purpose of this post marketing surveillance study is to prospectively evaluate whether patients monitored by ACRODAT® with appropriate clinical decisions based on disease activity status will benefit from improved treatment outcomes both in the short and in the long term.
Eligibility Criteria
Inclusion Criteria:
1. All patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve;
2. A follow-up visit is scheduled or anticipated for the patient at least once every year;
3. 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 Criteria:
1. Patients who are surgically cured and remain controlled for at least 3 years;
2. Patients who are unable to understand the nature of the study and/or unwilling to sign an informed consent;
3. Patients who are unwilling to abide by the guidelines of the study;
4. Patients participating in any clinical trial on an investigational medicine or software medical device/evaluation tool for acromegaly.
Source: ClinicalTrials.gov (NCT04349839). StuddyBuddy aggregates publicly available trial information.