NCT02053831

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

January 31, 2014

Last Update Submit

May 15, 2023

Conditions

Superficial Musculoaponeurotic System (SMAS) Procedure

Keywords

plastic surgery

Outcome Measures

Primary Outcomes (1)

  • Physician Satisfaction

    Investigator satisfaction will be judged by ease of product use, successful reinforcement, and total time for procedure to be completed.

    1 year

Secondary Outcomes (1)

  • Patient Satisfaction

    1 year

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinics

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ponte Vedra Plastic Surgery

Ponte Vedra Beach, Florida, 32083, United States

Location

The Few Institute for Aesthetic Plastic Surgery

Chicago, Illinois, 60611, United States

Location

Eye and Ear Institute

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Arikha Moses, Ph.D

    Chief Scientific Officer, Founder

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 4, 2014

Study Start

November 1, 2011

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

US(3)