Superficial Musculoaponeurotic System (SMAS) ProcedureNCT02053831
GalaFlex Mesh in Facelift
An observational study of Superficial Musculoaponeurotic System (SMAS) Procedure, run by C. R. Bard at 3 sites in United States.
Trial summary
In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Superficial Musculoaponeurotic System (SMAS) Procedure
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Jun 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinics
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
- Subject is unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
- Subject has known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
- Subject has any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
- Subjects has diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
- Active herpes labialis
- Subject is infected with HIV and/or received or may receive immunosuppressive therapy over the course of the study (such as rheumatoid arthritis).
Show all 15Show fewer
- Received any experimental drug or device within the previous three months.
- Known alcohol or drug abuser.
- Female subject who is pregnant or lactating or 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.
- Possesses any psychological condition, or is under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s),would constitute an unwarranted risk.
- Presents with severe jowling or severe cervical skin redundancy.
- Subject is currently a smoker or is a prior smoker who quit in the last 12 months.
- Active abscess or infection
- Currently involved with claims for, or is accepting, workers compensation
- Currently engaged in medical malpractice litigation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Few Institute for Aesthetic Plastic Surgery
Chicago, Illinois, 60611
Eye and Ear Institute
Chicago, Illinois, 60612
Ponte Vedra Plastic Surgery
Ponte Vedra Beach, Florida, 32083
About this study
In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.
- Keywords
- plastic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Satisfaction
Investigator satisfaction will be judged by ease of product use, successful reinforcement, and total time for procedure to be completed.
Measured: 1 year
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction will be judged by the difference between pre- and post-surgery answers to Quality of Life questionnaires.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startNov 2011
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Musculoaponeurotic System (SMAS) ProcedureStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Responsible party
- Sponsor
- Investigators
- Arikha Moses, Ph.D, Study director, Chief Scientific Officer, Founder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053831
- Sponsor's protocol ID
- CP-1040
- Status last verified
- May 2023
- First submitted
- 31 Jan 2014
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
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
- GalaFlex Mesh in Facelift
- ClinicalTrials.gov ID
- NCT02053831
- Acronym / sponsor ID
- CP-1040
- Keywords
- plastic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Tepha, Inc.
- Study start
- Nov 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Feb 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.
In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinics
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 (15 listed)
- Subject is unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
- Subject has known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
- Subject has any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
- Subjects has diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
- Active herpes labialis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician Satisfaction
Time frame: 1 year
Investigator satisfaction will be judged by ease of product use, successful reinforcement, and total time for procedure to be completed.
1 secondary outcome
Patient Satisfaction
Time frame: 1 year
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.
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.
Arikha Moses, Ph.D study director
Chief Scientific Officer, Founder
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Musculoaponeurotic System (SMAS) Procedure, run by C. R. Bard at 3 sites in United States.
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 15 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.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Physician Satisfaction (time frame: 1 year). 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.