Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03702556
Eligibility Criteria:
Inclusion Criteria:
* Female over 18 years old
* Unilateral mastectomy without breast reconstruction
* Unilateral mastectomy with DIEP flap breast reconstruction (with or without sensory nerve restoration)
* At least six months after the operation
* Informed consent
Exclusion Criteria:
* Bilateral mastectomy / breast reconstruction
* Previous surgery, disease or treatment of the contralateral breast
* Active disease / metastasis
* Previous radiation therapy on the chest or axilla
* Diseases associated with neuropathy (e.g. diabetes mellitus)
* Previous brain surgery
* Previous allergic reactions to adhesives or plasters
* Any MRI exclusion criteria:
* No piercings or other iron materials (except a metal brace behind front teeth)
* Claustrophobia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03702556
Study Brief:
Protocol Section:
NCT03702556