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

NCT03299712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1008

Last updated 2019-10-23

No results posted yet for this study

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 negative skin test prior to receiving treatment. The incidence of granuloma formation will be monitored.

Conditions

  • Granulomatous Disorder

Interventions

DEVICE

ArteFill

soft tissue filler

Sponsors & Collaborators

  • Suneva Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299712 on ClinicalTrials.gov