ACRODAT Prospective Evaluation Study

NCT ID: NCT04349839

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2025-02-01

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).

Conditions

Acromegaly

Keywords

Insulin-like growth factor-I (IGF-I); Growth hormone (GH); Disease control

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ACRODAT study arm

No intervention

Acrodat software

Intervention Type: DEVICE

Acrodat is a newly developed software medical device to access disease activity in acromegaly based on five parameters: IGF-I, tumour size, comorbidities, symptoms and quality of life.

Standard Practice Arm

No intervention

No interventions assigned to this group

Interventions

Acrodat software

Acrodat is a newly developed software medical device to access disease activity in acromegaly based on five parameters: IGF-I, tumour size, comorbidities, symptoms and quality of life.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Århus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

237269

Identifier Type: -

Identifier Source: org_study_id