Breast ImplantsPhase 2NCT01874652
Assessment of Safety & Efficacy of Light Weight Breast Implant
A Phase 2 study testing Light Weight Breast Implants in people with Breast Implants, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implants
- What is being tested?
- Light Weight Breast Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 2
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Genetic women at ages 18 to 65 seeking breast enlargement
- Signed informed consent
- Agreement to complete all required follow up visits
- A medically acceptable candidate
- Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)
Who cannot join
- Patients with active infection anywhere in their body
- Women who are currently pregnant or nursing
- Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
- Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
- Patients with a history of psychiatric treatment
- Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants)
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- Expected allergies or extraordinary immune response to implants
- Wound healing impairments or heavy burn scars
- Existing costal injuries
- The Patient Participated in an investigational trial within 30 days of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.
Read the detailed description
This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.
- Conditions
- Breast Implants
- Being tested
- Light Weight Breast Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Weight Breast ImplantsDevice
Light Weight Breast Implants
| Study group | Role | What they receive |
|---|---|---|
| Light Weight Breast Implants | Experimental | Assessment of Safety and Efficacy of Light Weight Breast Implant Receives: Device: Light Weight Breast Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
No reoperation
Measured: during 6 months follow up period
Secondary outcomes (1)
Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ImplantsStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Noam Calderon, md, Principal investigator, Bnai-Zion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874652
- Sponsor's protocol ID
- 0007-13-BNZ
- Status last verified
- Dec 2014
- First submitted
- 23 May 2013
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety & Efficacy of Light Weight Breast Implant
- ClinicalTrials.gov ID
- NCT01874652
- Acronym / sponsor ID
- 0007-13-BNZ
- Conditions
- Breast Implants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2013 (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.
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.
Detailed description
This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light Weight Breast Implants | Experimental | Device: Light Weight Breast ImplantsAssessment of Safety and Efficacy of Light Weight Breast Implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Genetic women at ages 18 to 65 seeking breast enlargement
- Signed informed consent
- Agreement to complete all required follow up visits
- A medically acceptable candidate
- Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)
Key exclusion criteria (10 listed)
- Patients with active infection anywhere in their body
- Women who are currently pregnant or nursing
- Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
- Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
- Patients with a history of psychiatric treatment
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 |
|---|---|---|
| Light Weight Breast ImplantsLight Weight Breast Implants | Device | Light Weight Breast Implants |
Primary outcome
No reoperation
Time frame: during 6 months follow up period
1 secondary outcome
Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.
Time frame: 6 month
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 3 Nov 2015.
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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.
Noam Calderon, md principal investigator
Bnai-Zion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Light Weight Breast Implants in people with Breast Implants, run by Bnai Zion Medical Center at 1 site in Israel.
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 5 inclusion and 10 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
No reoperation (time frame: during 6 months follow up period). 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 3 Nov 2015.