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To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including injection site local reactions and biodegradability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE Classic s | Treatment with YVOIRE Classic s |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE Classic s | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device-related Adverse Events | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Subject who receive hyaluronic acid filler into the nasolabial folds
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| Name | Affiliation | Role |
|---|---|---|
| Q Li | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | YVOIRE Classic s | YVOIRE Classic s |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | YVOIRE Classic s | Treatment with YVOIRE Classic s YVOIRE Classic s |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Device-related Adverse Events | Posted | Count of Participants | Participants | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years. |
|
|
Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YVOIRE Classic s | Treatment with YVOIRE Classic s YVOIRE Classic s | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Leader | LG Chem | 82-2-6987-4148 | sodam@lgchem.com |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 503 |
| 10 |
| 503 |
| 55 |
| 503 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Extremity injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arrhythmia | Vascular disorders | Non-systematic Assessment |
|
| Endometrial lesion | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gastric polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung cancer | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cervical intraepithelial neoplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Polyps of duodenum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ectopic pregnancy | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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