Trial Outcomes & Findings for Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s (NCT NCT02334358)

NCT ID: NCT02334358

Last Updated: 2019-03-13

Results Overview

Recruitment status

COMPLETED

Target enrollment

503 participants

Primary outcome timeframe

Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.

Results posted on

2019-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	YVOIRE Classic s YVOIRE Classic s
Overall Study STARTED	503
Overall Study COMPLETED	494
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	YVOIRE Classic s n=494 Participants Treatment with YVOIRE Classic s YVOIRE Classic s
Age, Continuous	42.44 years STANDARD_DEVIATION 9.85 • n=5 Participants
Sex: Female, Male Female	480 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment China	494 participants n=5 Participants

PRIMARY outcome

Timeframe: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.

Outcome measures

Outcome measures
Measure	YVOIRE Classic s n=503 Participants Treatment with YVOIRE Classic s YVOIRE Classic s
Incidence of Device-related Adverse Events	16 Participants

Adverse Events

YVOIRE Classic s

Serious events: 10 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	YVOIRE Classic s n=503 participants at risk Treatment with YVOIRE Classic s YVOIRE Classic s
Respiratory, thoracic and mediastinal disorders Bronchitis	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Injury, poisoning and procedural complications Extremity injury	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Vascular disorders Arrhythmia	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Reproductive system and breast disorders Endometrial lesion	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric polyps	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Respiratory, thoracic and mediastinal disorders Lung cancer	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Reproductive system and breast disorders Cervical intraepithelial neoplasia	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polyps of duodenum	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Reproductive system and breast disorders Ectopic pregnancy	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Musculoskeletal and connective tissue disorders Arthritis	0.20% 1/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.

Other adverse events

Other adverse events
Measure	YVOIRE Classic s n=503 participants at risk Treatment with YVOIRE Classic s YVOIRE Classic s
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	10.9% 55/503 • Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.

Additional Information

Study Leader

LG Chem

Phone: 82-2-6987-4148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER