Granulomatous DisorderNCT03299712
Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds
A study testing ArteFill in people with Granulomatous Disorder, run by Suneva Medical, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Granulomatous Disorder
- What is being tested?
- ArteFill
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Feb 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or non-pregnant female 18 years of age or older.
- Subject has provided written and verbal informed consent.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- 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.
- Subject has a documented negative skin test.
Who cannot join
- Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
- 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.).
- Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)
- 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
Show all 26Show fewer
- 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
- 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.
- Subject has a history of multiple severe allergies or allergies manifested by anaphylaxis.
- Subject has a history of allergy to lidocaine.
- 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.
- The subject has known hypersensitivity or previous allergic reaction to any of the components of the study devices not previously mentioned.
- Subject is undergoing or planning to undergo desensitization injections to meat products.
- Subject has any condition which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- 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.
- -
About this study
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.
Read the 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.
- Conditions
- Granulomatous Disorder
- Being tested
- ArteFill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArteFillDevice
soft tissue filler
| Study group | Role | What they receive |
|---|---|---|
| ArteFill | Other | 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. Receives: Device: ArteFill |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of granuloma formation.
To determine the incidence of granuloma formation.
Measured: 5 years
Incidence of unanticipated adverse events
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.
Measured: 5 years
Incidence of anticipated adverse events
The incidence of anticipated adverse events will be assessed at each follow-up visit.
Measured: 5 years
Secondary outcomes (1)
Assess of subject satisfaction
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study startSep 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatous DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suneva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299712
- Sponsor's protocol ID
- 521-01
- Status last verified
- Oct 2019
- First submitted
- 17 Nov 2014
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Post-approval Study of Artefill for Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03299712
- Acronym / sponsor ID
- 521-01
- Conditions
- Granulomatous Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Suneva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArteFill | Other | Device: ArteFillThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male or non-pregnant female 18 years of age or older.
- Subject has provided written and verbal informed consent.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- 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.
- Subject has a documented negative skin test.
Key exclusion criteria (26 listed)
- Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
- 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.).
- Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)
- 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:
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 |
|---|---|---|
| ArteFillsoft tissue filler | Device | ArteFill |
Primary outcome
The incidence of granuloma formation.
Time frame: 5 years
To determine the incidence of granuloma formation.
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.
Incidence of anticipated adverse events
Time frame: 5 years
The incidence of anticipated adverse events will be assessed at each follow-up visit.
1 secondary outcome
Assess of subject satisfaction
Time frame: 5 years
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 23 Oct 2019.
Related trials for Granulomatous Disorder
RecruitingObservational study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Presumed Trematode Induced Uveitis, Uveitis
RecruitingObservational study
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
Active, not recruitingEarly Phase 1
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
Chronic Granulomatous Disease
Active, not recruitingPhase 1/2
High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease
Chronic Granulomatous Disease Transplant
RecruitingPhase 1/2
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Crohn's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ArteFill in people with Granulomatous Disorder, run by Suneva Medical, Inc..
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 26 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 23 Oct 2019. 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 incidence of granuloma formation. (time frame: 5 years). The study lists 3 primary outcomes in all. 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 23 Oct 2019.