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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT05258305
Eligibility Criteria:
Augmentation Subjects
Inclusion Criteria:
* Female patients \> 22 years and \< 65 years of age.
* Patients with a BMI \< 35.
* Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant.
* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
* Patients must be non-smokers.
* Patients with available/adequate harvest sites for fat grafting.
* Anticipated harvested fat volume between 200 and 700 cc.
* Anticipated fat injection volume between 50 and 350 cc per breast.
* Anticipated breast implant volume between 200 and 550 cc.
* Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.
Exclusion Criteria:
* Skin rash in the treatment area.
* Patients who smoke or use nicotine products.
* Patients with bleeding disorders or currently taking anticoagulants.
* Patients with history of trauma or surgery to the treatment area.
* Patients with history of breast cancer.
* Active, chronic, or recurrent infection.
* Compromised immune system.
* Hypersensitivity to analgesic agents.
* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
* Untreated drug and/or alcohol abuse.
* Pregnant or breastfeeding.
* Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.
* Patients who do not wish to have the study area (breast) photographed.
Reconstruction Subjects
Inclusion Criteria:
* Female patients \> 18 years and \< 65 years of age.
* Patients with a BMI \< 35.
* Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant.
* Patient is at least 1 year post-completion of chemotherapy.
* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
* Patients must be non-smokers.
* Patients with available/adequate harvest sites for fat grafting.
* Anticipated harvested fat volume between 200 and 700 cc.
* Anticipated fat injection volume between 50 nd 350cc per breast.
* Anticipated breast implant volume (if applicable) between 200 and 550 cc.
* Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.
Exclusion Criteria:
* Skin rash in the treatment area.
* Patients who smoke or use nicotine products.
* Patients with bleeding disorders or currently taking anticoagulants.
* Patients undergoing active treatment for breast cancer.
* Active, chronic, or recurrent infection.
* Compromised immune system.
* Hypersensitivity to analgesic agents.
* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
* Untreated drug and/or alcohol abuse.
* Pregnant or breastfeeding.
* Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.
* Patients who do not wish to have the study area (breast) photographed.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT05258305
Study Brief:
Protocol Section:
NCT05258305