ACRODAT Prospective Evaluation Study

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    500
  • sponsor
    University of Aarhus
Updated on 24 May 2022
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insulin-like growth factor
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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.

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 ACRODAT®. Patients newly enrolled will be followed-up over a 2 year period. Patients will be assigned to the ACRODAT® group or the Standard Practice group according to a central randomisation. Patients assigned to the ACRODAT® arm will be followed up with the treating physician using ACRODAT® at every visit. The frequency of visits will be according to standard practice in the clinic. Patients not followed up with ACRODAT® will be followed-up in accordance with the standard medical practice of the hospital where they have been recruited, until study completion (Standard Practice arm).

Details
Condition Acromegaly
Treatment Acrodat software
Clinical Study IdentifierNCT04349839
SponsorUniversity of Aarhus
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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