Clinical trial NCT02081157: Use of GalaFlex in Ptotic Breast
Official title: Use of GalaFlex in Ptotic Breast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ptotic Breast
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Tepha, Inc.
First posted: 2014-03-07
Enrollment: 69
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with ptotic breasts having elective mastopexy, with or without reduction, with the use of GalaFLEX mesh.

Brief summary: This study is to assess the physician preference in the clinical performance of the GalaFLEX mesh in soft tissue reinforcement during elective (cosmetic) plastic surgery to the breast, in particular the breast lift mastopexy and breast reduction procedures


Eligibility criteria: Inclusion Criteria:

1. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
2. Be at least 21 years of age.
3. Be willing and able to comply with the requirements of the protocol.
4. Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
5. Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria:

1. Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
2. Subjects with known severe allergies manifested by a history of anaphylaxis or allergy to GalaFLEX mesh, poly-4-hydroxybutyrate (P4HB), a resorbable polymer, or silicone.
3. Subjects with known active infection and/or who received or are targeted to receive immunosuppressive therapy over the course of the study (such as rheumatoid arthritis).
4. Subjects who received any experimental drug or device within the previous three months.
5. Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
6. Possessed any psychological condition, or was under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.
7. Have collagen-vascular, connective disease, or bleeding disorders.
8. Have a BMI that is greater than or equal to 30.
9. Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
10. Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs.
11. Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit.
12. Have concomitant unrelated condition of breast/chest wall/skin.
13. Have undergone previous breast surgery with the exception of breast biopsy.
14. Subject is currently a smoker or is a prior smoker who quit in the last 12 months.
15. Currently involved with claims for, or is accepting workers compensation.
16. Currently engaged in medical malpractice litigation.

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Primary outcomes:
measure: The primary outcome for study success is defined as ptosis correction and maintenance of the surgical correction
timeFrame: 1year
Secondary outcomes:
Other outcomes:
measure: Long term visibility: Mammography and ultrasound will be used to evaluate the presence of the mesh or potential for mesh interference in evaluation of the breast tissue.
timeFrame: 1 year
measure: Investigator satisfaction with the surgical implantation/usage of GalaFLEX Scaffold based on a satisfaction questionnaire completed at procedural and follow up timepoints
timeFrame: 1 year
measure: Patient satisfaction based on a survey
timeFrame: 1 year
measure: Adverse event summary
timeFrame: 1 year
Locations:
Study officials:
affiliation: Tepha, Inc.
name: Connie Garrison
role: STUDY_DIRECTOR
References: