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OpenTrials
Completed

NCT Number: NCT02081157

Use of GalaFlex in Ptotic Breast

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

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Key information

Conditions

Ptotic Breast

Age range

21 year–99 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • Be at least 21 years of age.
  • Be willing and able to comply with the requirements of the protocol.
  • Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
  • 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

  • Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
  • 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.
  • 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).
  • Subjects who received any experimental drug or device within the previous three months.
  • 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.
  • 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.
  • Have collagen-vascular, connective disease, or bleeding disorders.
  • Have a BMI that is greater than or equal to 30.
  • Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
  • Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs.
  • Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit.
  • Have concomitant unrelated condition of breast/chest wall/skin.
  • Have undergone previous breast surgery with the exception of breast biopsy.
  • Subject is currently a smoker or is a prior smoker who quit in the last 12 months.
  • Currently involved with claims for, or is accepting workers compensation.
  • Currently engaged in medical malpractice litigation.

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Treatment and study plan

GalaFlex Mesh

Device

Primary outcomes

  1. The primary outcome for study success is defined as ptosis correction and maintenance of the surgical correction

    Time frame: 1year

    Correction of ptosis at 3 months must be Grade 0, Pseudoptosis, or Grade 1, and maintenance of ptosis correction at 12 months is demonstrated by a classification of ptosis Grade 1 or less

Other outcomes

  1. 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.

    Time frame: 1 year

    Long term visibility

  2. Investigator satisfaction with the surgical implantation/usage of GalaFLEX Scaffold based on a satisfaction questionnaire completed at procedural and follow up timepoints

    Time frame: 1 year

    To determine the role that GalaFLEX scaffold plays in MD's perception of the ability to obtain a successful result, MD's provide assessments of the surgical procedures such as mesh handling, ease of placement. At follow up timepoints, a satisfaction questionnaire is completed to assess satisfaction with overall procedural results

  3. Patient satisfaction based on a survey

    Time frame: 1 year

    Patient satisfaction

  4. Adverse event summary

    Time frame: 1 year

    Adverse Events reported in the study will be evaluated for attribution to the devoce/procedure

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Collaborators

  • Tepha, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2014
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.