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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT03830294
Eligibility Criteria:
Inclusion Criteria:
* undergoing unilateral mastectomy due to breast cancer confirmed by histological examination
* had undergone mastectomy at least six months prior to the start of the study or patients who completed radiation therapy at least two months prior
* without evidence of postoperative relapse
* wearing conventional (non-adhesive) breast prostheses
* without abnormal skin or skin lesions
* patients without progressive lymphedema;
* interested in conventional and self-adhesive breast prostheses.
Exclusion Criteria:
* with incomplete healing of their surgical wounds
* undergoing chemoradiotherapy or who received chemoradiotherapy less than two months prior to the beginning of the study
* with skin conditions that do not meet the requirements
* whose remaining breast is not within the study's size range
* with significant life changes during the study, including divorce, unemployment or depression; 6) relapsed during the observation period
* had a reaction to the first skin test and who were not able to receive the second skin test.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT03830294
Study Brief:
Protocol Section:
NCT03830294