At a glance
ClinicalIndex Comparison RecordN/ACompleted· 94 enrolled
Drug / intervention
Questionnaire and Physical Examdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
In Brief
An observational study evaluating Questionnaire and Physical Exam for Postoperative Pain. Completed, enrolled 94 participants.
Detailed Summary
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionMar 2010
TodayJul 2026
First PostedFeb 26, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.3 years ago
Interventions
Questionnaire and Physical Examdrug
A 10-question survey and a six-item physical exam were completed.