Breast Asymmetry Between Native Breast and Reconstructed BreastNCT02649283
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
A study testing OrbiSymm device and Breast symmetrisation in people with Breast Asymmetry Between Native Breast and Reconstructed Breast, run by Orbix Medical Ltd. at 1 site in Italy.
Trial summary
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Asymmetry Between Native Breast and Reconstructed Breast
- What is being tested?
- OrbiSymm device and Breast symmetrisation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Oct 2019
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent before any study specific tests or procedures are done.
- Female subject between the age of 20 and 65 years old
- Underwent breast reconstruction following unilateral mastectomy and referred to contra lateral symmetrisation procedure that requires reduction of at least 150gr (clarification: the procedure of reconstruction and symmetrisation may be performed simultaneously).
- Breast size ≥D
- BMI≤ 32
Who cannot join
- Pregnant or lactating woman.
- Subject with history of surgical procedures involving the ribs and rib cage.
- Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
- Subject with breast implants.
- Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
- Subject suffering from reconstruction failure, skin necrosis or implant infection.
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- Subject with diagnosed or suspected auto-immune disease.
- Subject with pathologies that affect blood coagulation, immune system or any treatment interfering with them.
- Subject with lesions due to radiation, ulceration, vascular anomalies or history of circulatory disorder.
- Subject suffering from a progressive fibrocystic disease, considered to be pre-cancerous, without mastectomy.
- Subject with concurrent diseases determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications such as obesity, smoking, diabetes, autoimmune disease, coagulopathy, chronic lung or severe cardiovascular disease.
- Use of drugs that might result in high surgical risk and/or significant postoperative complication, including drugs that would interfere with blood clotting.
- Psychological instability, inappropriate attitude or motivation.
- Subject participating or that has participated until one month prior to planned procedure, in another investigational study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Instituto Nazionale dei Tumori di Roma "Regina Elena"
Rome, 00144
Roy De Vita, M.D., Ph.D., +39-06-3291296, roydevita@roydevita.it
Roy De Vita, M.D., Ph.D.
About this study
Official title: Phase IV, Multicenter, Open Label, Non Randomized Comparative Group Study to Assess the Safety and Performance of the OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation Following Breast Reconstruction Post Mastectomy
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.
Read the detailed description
The device has the CE Mark and will be used in the indication for which it is approved.
Up to 60 patients will be assigned to the study (up to 30 patients for Orbix procedure, and up to 30 patients without Orbix procedure (only routine reduction/symmetrisation). Patients will return to the clinic for follow-up at 1, 3, 6, 12 \& 24 months (last visit will be optional).
- Being tested
- OrbiSymm device, Breast symmetrisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrbiSymm deviceDevice
Also called Contralateral symmetrisation using OrbiSymm device
Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.
Breast symmetrisationProcedure or surgery
Also called Contralateral symmetrisation
Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.
| Study group | Role | What they receive |
|---|---|---|
| Breast symmetrisation with OrbiSymm | Other | Standard surgical intervention of up to 30 patients including placement of the OrbiSymm device Receives: Device: OrbiSymm device |
| Breast symmetrisation without device | Other | Standard surgical intervention of up to 30 patients without the Orbix device; only routine reduction/symmetrisation intervention Receives: Procedure: Breast symmetrisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
Stability of symmetrisation as measured by comparison of patients' breast measurements before the procedure and during the FU period (measures will be taken by the surgeon in cm)
Measured: up to 24 months
Secondary outcomes (3)
Evaluate the performance OrbiSymm
Performance will be measured by comparison of patients' ptosis grade before the procedure and during the FU period (using ptosis grade scale 0-4)
Measured: up to 24 months
Evaluate the long term safety of OrbiSymm
Demonstration of the safe implantation of the device by means of analysis of overall incidence and severity of procedure \& device related adverse events after 1, 3, 6, 12 and 24 months (last visit will be optional). Summarizing the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 24 months
Patient satisfaction
Patients will complete questionnaire regarding their satisfaction before the procedure and after 3, 6, 12 and 24 months (last visit will be optional).
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Asymmetry Between Native Breast and Reconstructed BreastStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orbix Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Prof. Gur, M.D., Ph.D., Study director, Medical Director, Orbix Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649283
- Sponsor's protocol ID
- OX CL03
- Status last verified
- Sep 2016
- First submitted
- 24 Dec 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Multicenter, Open Label, Non Randomized Comparative Group Study to Assess the Safety and Performance of the OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation Following Breast Reconstruction Post Mastectomy
- ClinicalTrials.gov ID
- NCT02649283
- Acronym / sponsor ID
- OX CL03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Orbix Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 7 Jan 2016 (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.
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.
Detailed description
The device has the CE Mark and will be used in the indication for which it is approved.
Up to 60 patients will be assigned to the study (up to 30 patients for Orbix procedure, and up to 30 patients without Orbix procedure (only routine reduction/symmetrisation). Patients will return to the clinic for follow-up at 1, 3, 6, 12 \& 24 months (last visit will be optional).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast symmetrisation with OrbiSymm | Other | Device: OrbiSymm deviceStandard surgical intervention of up to 30 patients including placement of the OrbiSymm device |
| Breast symmetrisation without device | Other | Procedure: Breast symmetrisationStandard surgical intervention of up to 30 patients without the Orbix device; only routine reduction/symmetrisation intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent before any study specific tests or procedures are done.
- Female subject between the age of 20 and 65 years old
- Underwent breast reconstruction following unilateral mastectomy and referred to contra lateral symmetrisation procedure that requires reduction of at least 150gr (clarification: the procedure of reconstruction and symmetrisation may be performed simultaneously).
- Breast size ≥D
- BMI≤ 32
Key exclusion criteria (14 listed)
- Pregnant or lactating woman.
- Subject with history of surgical procedures involving the ribs and rib cage.
- Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
- Subject with breast implants.
- Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
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 |
|---|---|---|
| OrbiSymm deviceAlso: Contralateral symmetrisation using OrbiSymm deviceBreast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams. | Device | Breast symmetrisation with OrbiSymm |
| Breast symmetrisationAlso: Contralateral symmetrisationBreast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams. | Procedure or surgery | Breast symmetrisation without device |
Primary outcome
Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
Time frame: up to 24 months
Stability of symmetrisation as measured by comparison of patients' breast measurements before the procedure and during the FU period (measures will be taken by the surgeon in cm)
3 secondary outcomes
Evaluate the performance OrbiSymm
Time frame: up to 24 months
Evaluate the long term safety of OrbiSymm
Time frame: up to 24 months
Patient satisfaction
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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.
Eyal Prof. Gur, M.D., Ph.D. study director
Medical Director, Orbix Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrbiSymm device and Breast symmetrisation in people with Breast Asymmetry Between Native Breast and Reconstructed Breast, run by Orbix Medical Ltd. at 1 site in Italy.
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 14 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murielle Agassi, M.Sc., MBA (+972-3-5688558, Muriell.Agassi@orbix-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period. (time frame: up to 24 months). 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 29 Sep 2016.