Breast AugmentationNCT02302001
Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
A study testing Silicone Implant in people with Breast Augmentation, run by Aristocrat Plastic Surgery and MedAesthetics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- Silicone Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- silicone breast implants candidate
Who cannot join
- history of breast cancer
- inability to conform to post operative questionnaire and recovery follow up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aristocrat Plastic Surgery & MedAesthetics
Great Neck, New York, 11021
Aristocrat Plastic Surgery
New York, New York, 10019
About this study
Official title: Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain
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.
Read the detailed description
Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.
- Conditions
- Breast Augmentation
- Being tested
- Silicone Implant
- Keywords
- Breast augmentation, Breast implants, Silicone implants, Breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Primary Breast Augmentation | Experimental | Not described Receives: Device: Silicone Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased postoperative pain and recovery after breast augmentation
Measured: Two weeks
Secondary outcomes (1)
Decreased risk of capsular contracture
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristocrat Plastic Surgery and MedAesthetics
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe-med, Tiger Biosciences, LLC.
- Responsible party
- Sponsor
- Investigators
- Kevin Tehrani, M.D., Principal investigator, Aristocrat Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302001
- Sponsor's protocol ID
- fwa00022532
- Status last verified
- Feb 2019
- First submitted
- 24 Nov 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain
- ClinicalTrials.gov ID
- NCT02302001
- Acronym / sponsor ID
- fwa00022532
- Conditions
- Breast Augmentation
- Keywords
- Breast augmentation, Breast implants, Silicone implants, Breast surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aristocrat Plastic Surgery and MedAestheticsUniversity, hospital or other
- Collaborators
- Erbe-med, Tiger Biosciences, LLC.
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Augmentation | Experimental | Device: Silicone Implant |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- silicone breast implants candidate
Key exclusion criteria (2 listed)
- history of breast cancer
- inability to conform to post operative questionnaire and recovery follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone Implant | Device | Primary Breast Augmentation |
Primary outcome
Decreased postoperative pain and recovery after breast augmentation
Time frame: Two weeks
1 secondary outcome
Decreased risk of capsular contracture
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Tehrani, M.D. principal investigator
Aristocrat Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Implant in people with Breast Augmentation, run by Aristocrat Plastic Surgery and MedAesthetics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased postoperative pain and recovery after breast augmentation (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.