Ptotic BreastNCT02081157
Use of GalaFlex in Ptotic Breast
An observational study of Ptotic Breast, run by C. R. Bard.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Ptotic Breast
- What is being tested?
- GalaFlex Mesh
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2012to 21 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with ptotic breasts having elective mastopexy, with or without reduction, with the use of GalaFLEX mesh.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
About this study
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
- Conditions
- Ptotic Breast
- Being tested
- GalaFlex Mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalaFlex MeshDevice
| Study group | Role | What they receive |
|---|---|---|
| Breast Mastopexy with or without reduction using GalaFlex Mesh | Breast mastopexy with or without reduction, using GalaFLEX mesh Receives: Device: GalaFlex Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for study success is defined as ptosis correction and maintenance of the surgical correction
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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start25 Jul 2012
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ptotic BreastStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Responsible party
- Sponsor
- Investigators
- Connie Garrison, Study director, Tepha, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081157
- Sponsor's protocol ID
- CP-1050
- Status last verified
- May 2023
- First submitted
- 4 Mar 2014
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of GalaFlex in Ptotic Breast
- ClinicalTrials.gov ID
- NCT02081157
- Acronym / sponsor ID
- CP-1050
- Conditions
- Ptotic Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Study start
- 25 Jul 2012 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Mastopexy with or without reduction using GalaFlex Mesh | – | Device: GalaFlex MeshBreast mastopexy with or without reduction, using GalaFLEX mesh |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with ptotic breasts having elective mastopexy, with or without reduction, with the use of GalaFLEX mesh.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalaFlex Mesh | Device | Breast Mastopexy with or without reduction using GalaFlex Mesh |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Garrison study director
Tepha, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Ptotic Breast, run by C. R. Bard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome for study success is defined as ptosis correction and maintenance of the surgical correction (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.