NCT02302001

Brief Summary

ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

November 24, 2014

Last Update Submit

February 3, 2019

Conditions

Breast Augmentation

Keywords

Breast augmentationBreast implantsSilicone implantsBreast surgery

Outcome Measures

Primary Outcomes (1)

  • Decreased postoperative pain and recovery after breast augmentation

    Two weeks

Secondary Outcomes (1)

  • Decreased risk of capsular contracture

    Three months

Study Arms (1)

Primary Breast Augmentation

EXPERIMENTAL
Device: Silicone Implant

Interventions

Silicone ImplantDEVICE
Primary Breast Augmentation

Eligibility Criteria

Age22 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • silicone breast implants candidate

You may not qualify if:

  • history of breast cancer
  • inability to conform to post operative questionnaire and recovery follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aristocrat Plastic Surgery & MedAesthetics

Great Neck, New York, 11021, United States

Location

Aristocrat Plastic Surgery

New York, New York, 10019, United States

Location

Study Officials

  • Kevin Tehrani, M.D.

    Aristocrat Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

November 26, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

US(2)