Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds

October 21, 2019 updated by: Suneva Medical, Inc.
This study is a five-year, multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill® in the course of clinical practice at approximately twenty-five centers and all subjects must have a previously documented negative skin test prior to receiving treatment. The incidence of granuloma formation will be monitored.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill® in the course of clinical practice at approximately twenty-five centers. All potential qualifying subjects at a given site should be given the opportunity to participate in the study. Inclusion and exclusion criteria will be limited to those in the approved labeling for ArteFill® and treatment will be according to the approved product labeling. Subjects must have a previously documented negative skin test prior to treatment. Follow-up for subject-reported potential adverse events and satisfaction data will be by mail or telephone questionnaire survey every six months for the first two years after the final treatment session and then every year for a total of five years of follow-up. The subject will be contacted by his or her investigator if a problem is identified in the questionnaire response as reviewed by the Sponsor or their designee. Potential adverse events reported in the follow-up questionnaires will be investigated further by means of office visits, as necessary, or via telephone.

Adverse events will be confirmed and reported by the investigators. If an adverse event is determined by the investigator to possibly be a granuloma, it will be investigated via histology. If a subject for whom an adverse event is reported has received additional aesthetic or non-aesthetic treatment to the affected area, available information on such treatment will be collected and the subject will be continued to be followed per protocol. Such subjects will not be excluded from the analysis, but will be evaluated separately. Effectiveness data will be collected during the study and will consist of the subject's assessment of satisfaction with treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1008

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is male or non-pregnant female 18 years of age or older.
  2. Subject has provided written and verbal informed consent.
  3. Subject is willing to comply with study instructions and return to the clinic for required visits.
  4. Subject is willing to withhold additional aesthetic implant therapies to the NLF [e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or implants: gortex, silastic, thread lift, etc.] for the duration of the study.
  5. Subject has a documented negative skin test.

Exclusion Criteria:

  1. Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.

  2. Subject has a history of systemic granulomatous diseases active or inactive (e.g.

    Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus, dermatomyositis, etc.).

  3. Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)

  4. Subject has been treated with any of the following in their NLF in the time intervals specified prior to the start of their participation in the study:

    • Bovine collagen - 6 months
    • Porcine or human collagen - one year
    • Hyaluronic acid - one year
    • Hydroxylapatite - one year
    • Autologous fat - at any time
    • Polymethylmethacrylate or other acrylates - at any time
    • Polyacrylamide - at any time
    • Polyethylene oxide - at any time
    • Polylactic acid - at any time
    • Liquid silicone - at any time
    • Other permanent implant material (FDA approved or not) - at any time
  5. Subject has had the placement of any surgical implants in the NL folds region (e.g., Gortex, Silastic implants, thread lifts, etc.) at any time.
  6. Subject has a history of multiple severe allergies or allergies manifested by anaphylaxis.
  7. Subject has a history of allergy to lidocaine.
  8. Subject has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
  9. The subject has known hypersensitivity or previous allergic reaction to any of the components of the study devices not previously mentioned.
  10. Subject is undergoing or planning to undergo desensitization injections to meat products.
  11. Subject has any condition which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
  12. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.

  13. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: ArteFill
This post-approval study will evaluate the continuing safety of ArteFill® as an injectable implant for correction of nasolabial folds over the course of five years post implantation, with a focus on determining the incidence of granuloma formation. Incidence of adverse events and subject satisfaction with respect to the subject's personal expectations will be assessed.
Device: ArteFill
soft tissue filler

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of granuloma formation.
Time Frame: 5 years
To determine the incidence of granuloma formation.
5 years
Incidence of unanticipated adverse events
Time Frame: 5 years
Safety will be assessed based on the incidence of serious unanticipated adverse events. Unanticipated adverse events will be characterized by the severity and relation to the implant product.
5 years
Incidence of anticipated adverse events
Time Frame: 5 years
The incidence of anticipated adverse events will be assessed at each follow-up visit.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess of subject satisfaction
Time Frame: 5 years
Subjects assessed their satisfaction using the 5-point Likert Scale Subject Satisfaction Assessment Scale. This scale has the following measurements: 1- Very Satisfied, 2=Satisfied, 3=Somewhat Satisfied, 4= Dissatisfied and 5=Very Dissatisfied.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suneva Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 521-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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