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| General |
| Study Status |
Noncompliant |
| 522 Number / Requirement Number |
PS230003 / PSS001 |
| Date Original Plan Accepted |
07/23/2024
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| Study Name |
Bateman Bottle Postmarket Surveillance Study
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| Device Name |
Breast Implant Removal Device (BIRD) previously the Bateman Bottle
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| Root Document Number |
DEN220082
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a multicenter, prospective post approval study to be conducted in the United States.
Subjects will be recruited from each study site's patient population presenting to the clinic for breast implant removal with a potential breast implant rupture. Patients with a ruptured breast implant who meet all inclusion/ exclusion criteria will be enrolled.
To characterize the postmarket safety of the use of the BIRD for the removal of ruptured breast implants and to report the location and texture of the removed implants.
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| Study Population |
Patients who present to a site requesting removal of their breast implant(s) will be screened for inclusion in this surveillance study. Final enrollment will occur during the procedure, if and only, the physician determines that one or both breast implants have ruptured.
INCLUSION CRITERIA:
Subjects must meet ALL of the following inclusion criteria (unless otherwise indicated, answers are to the subject's "knowledge"):
1. Patients at least 22 years of age at the time of the surgery.
2. Patients seeking breast implant removal of a ruptured silicone breast implant. The Investigator will confirm that the implant is ruptured prior to enrollment. For asymptomatic patients, this will be confirmed via ultrasound; if results are equivocal, an MRI will be performed. For symptomatic patients, this will be confirmed via MRI. With patients under 35 with dense breast tissue, an ultrasound will be completed.
3. Patients must undergo screening imaging mammogram and other additional imaging as deemed necessary by the surgeon or investigator to confirm there is no breast cancer present.
4. Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial.
EXCLUSION CRITERIA:
Subjects must NOT meet ANY of the following criteria (unless otherwise indicated, answers are to
the subject's "knowledge"):
1. Currently pregnant or breast feeding, or discontinued breast feeding within the previous 6 months.
2. Have, or under treatment for, any condition or disease that may constitute an unwarranted surgical risk in the opinion of the investigator.
3. History of prior breast reconstruction
4. Family history of breast cancer, without sufficient radiographic screening.
5. Current diagnosis or past history of cancer, precancerous lesions, or cancerous lesions of the breast.
6. If patient has a breast specimen that cannot be removed prior to use of BIRD, they must be excluded from the study.
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| Sample Size |
Number of subjects: Up to 100 subjects.
Assumptions for sample size estimation: N/A
Number of sites: Up to 6 sites
Sites location: US
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| Key Study Endpoints |
Safety Endpoints
Primary:
Postmarket reporting of the nature, severity, and frequency of observed adverse events during use of the BIRD for extraction of ruptured silicone breast implants.
Secondary:
Report the ability of the BIRD to facilitate removal of the breast implant.
Document the breast implant location, i.e. pre-pectoral or sub-pectoral.
Document the implant type, i.e. smooth or textured.
Document device-related statistics, e.g. duration of use during the procedure.
Document the presence or absence of additional implanted devices (e.g., acellular dermal matrix).
Document the presence of tissue adherence of the implant.
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| Follow-up Visits and Length of Follow-up |
Subjects will be assessed during surgery and 2 weeks following surgery
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