None listed
Conditions
Interventions
Medical Device : Implantation of BeautraGel
Sponsors
Osstem Implant
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women over the age of 22 who want breast augmentation surgery or women of any age who want breast reconstruction surgery 2) Those who want breast augmentation and reconstruction surgery as follows - Those who want to undergo surgery for the purpose of enlargement of both breasts - Those who want breast reconstruction with implants after total mastectomy for removal of planned breast cancer lesions ( Including those who need augmentation surgery on the other side when one breast is reconstructed) 3) A person who voluntarily consented in writing 4) A person who can follow the procedures of clinical trials well and adhere to the visit schedule
Exclusion criteria
Exclusion criteria: 1) Those who have previously undergone breast augmentation or breast reconstruction surgery 2) Patients with autoimmune disease 3) Patients with uncontrolled active infectious disease and/or abscesses 4) Hepatitis B or C carriers 5) A person who cannot insert an artificial breast due to tissue defect due to radiation therapy, etc., or a person who needs radiation treatment after implantation of an artificial breast 6) For those who want breast augmentation surgery, patients who fall under Breast Imaging-Reporting and Data System (BI-RADS) category 3 or 4 on breast ultrasound 7) Patients with keloid skin 8) People with uncontrolled diabetes that can impair wound healing 9) Those who have disqualification such as the inability to perform general anesthesia as a result of laboratory tests or ECG 10) Those who have metal materials that affect the MRI examination, such as a cardiac pacemaker or a cerebrovascular clip, or are unable to perform MRI measurements due to claustrophobia, etc. 11) Those whose mental status may affect the clinical trial progress due to alcohol or drug abuse 12) Those who are unable to proceed with the survey conducted in this clinical trial 13) Those who participated in other clinical trials within 30 days prior to screening 14) Women who are pregnant, lactating, or planning to become pregnant for 2 years during a confirmatory clinical trial, or medically acceptable methods of contraception (e.g., sterilization, intrauterine contraceptives, oral contraceptives in combination with barrier contraception, other hormone delivery systems combined with barrier contraception; Women of childbearing age who do not use diaphragms or condoms with contraceptive creams, jellies or foams) ( Women of childbearing age must have a negative pregnancy test before applying the clinical trial medical device.) 15) In case the other investigators judge it to be inappropriate for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate whether the rate of rupture at each visit is within 1% at the time of 2 years after application of the clinical trial medical device;Evaluate whether the capsular construction rate is within 5% at each visit by 2 years after application of the clinical trial medical device | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of ALCL expression rate at each visit after application of clinical trial medical device;Evaluation of adverse events and vital signs, laboratory tests, and abnormal fluctuations in physical examinations after application of medical devices for clinical trials | — |
Countries
Korea, Republic of
Contacts
Public ContactMINJI KIM
Seoul National University Bundang Hospital
Outcome results
None listed