Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-29 @ 3:02 PM
Study NCT ID:
NCT04185961
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2019-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
Detailed Description:
1. Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
2. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
3. Apply EVERA RAPHA for 4 weeks
3\. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
2. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
3. Apply EVERA RAPHA for 4 weeks
3\. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: