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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01396993
Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom \>10%\* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
* BIRADS IV, V or VI are eligible
* \> 18 years of age
* Psychological and physical capable of understanding and performing the trial
* Signed written informed consent \* If oncologic safety necessitates to resect more than half of one breast quadrant
Exclusion Criteria:
* Inflammatory breast cancer
* Progression after neoadjuvant therapy
* Pregnant women
* Patients unable to perform surgery under general anaesthesia
* Bilateral breast lesions
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01396993
Study Brief:
Protocol Section:
NCT01396993