Brief Title
ACRODAT Prospective Evaluation Study
Official Title
Post-marketing Surveillance Study to Evaluate the Clinical Utility of ACRODAT in an International, Randomised, Non-interventional Study
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 (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.
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 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).
Study Type
Observational
Primary Outcome
Changes in IGF-I levels
Secondary Outcome
Change in ACRODAT® score
Condition
Acromegaly
Intervention
Acrodat software
Study Arms / Comparison Groups
ACRODAT study arm
Description: No intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
500
Start Date
April 15, 2020
Completion Date
March 2023
Primary Completion Date
April 1, 2021
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.
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
, 78450000, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04349839
Organization ID
237269
Responsible Party
Sponsor
Study Sponsor
University of Aarhus
Study Sponsor
, ,
Verification Date
September 2019