Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are genetically female and aged 18 or older
• People who have given written consent to participate in the study
• People who need tissue expansion as part of breast reconstruction, which may include immediate reconstruction after surgery
• People whose clinical condition is suitable for this type of breast reconstruction, as determined by the treating doctor
• People who have enough body fat in donor areas such as the abdomen, buttocks, hips, or thighs, as assessed by the plastic surgeon
• People who have completed radiotherapy and chemotherapy at least one year before the planned surgery
• People with a BMI between 18.5 and 30.0
• People who are physically and mentally able to understand and follow the surgeon's instructions
• People who are able and willing to attend all required study appointments and follow-up visits

For sub-study participants only:

• People who give additional consent to have an MRI scan with contrast dye

Who may not be able to join:

• People who are currently pregnant or breastfeeding, or who become pregnant or breastfeed at any point during the trial
• People with abnormal blood or biochemical test results following chemotherapy
• People considered to be at high surgical risk, as determined by the treating doctor
• People whose breast width is larger than 18 cm
• People who have remaining tumour in or near the area where tissue expansion is planned
• People who have metastatic breast cancer (cancer that has spread to other parts of the body)
• People with significantly drooping breasts or poor skin quality
• People who do not have enough suitable tissue at the planned expansion site due to previous radiotherapy, skin ulceration, blood vessel involvement, a history of poor wound healing, or scarring from a mastectomy
• People with insufficient chest wall tissue due to radiation damage, tight skin grafts, or removal of the major chest muscle
• People with a current or previous infection in the area where expansion is planned
• People who have a condition that prevents them from having an MRI scan, such as an implanted metal device, claustrophobia, or another relevant medical condition
• People with autoimmune conditions such as lupus or scleroderma, or people whose immune system is suppressed due to medication
• People with a known sensitivity to silicone
• People who are currently smoking
• People who have previously had a breast reconstruction attempt
• People considered to be part of a vulnerable population, as determined by the investigator (confirm with trial site)
• People who are employed by or related to the study sponsor, trial sites, or investigators
• People who do not live in the same country where the procedure is being performed, making follow-up visits impossible
• People who are currently participating in another clinical study that may affect the results or follow-up requirements of this trial

Important: Always verify eligibility with the trial site directly before applying.