Reconstruction of the Breast Nipple and Areola ComplexNCT04051892
Multicenter Study Evaluating the FixNip™ NRI Safety and Performance
A study testing FixNip™ NRI in people with Reconstruction of the Breast Nipple and Areola Complex, run by FixNip Ltd at 1 site in Israel.
Trial summary
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women only
- Conditions the study is for
- Reconstruction of the Breast Nipple and Areola Complex
- What is being tested?
- FixNip™ NRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Oct 2020to 22 Dec 2022
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 22-70 years.
- Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study.
- History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex.
- At least 3 months post breast reconstruction surgery.
- Baker scale grade I or II capsular contracture.
- No evidence of any systemic or chronic disease that might influence wound healing and infection rate.
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- Event free post breast and/or nipple reconstruction procedure, i.e. no skin infections or related infections that mandated antibiotic therapy, no wound dehiscence or any other related medical complications.
- Pinch test of intended nipple location on affected breast of at least 15 mm.
- Patient is willing to postpone tattooing until the end of follow-up period.
- Patient is willing and able to give their written informed consent.
Who cannot join
- Active malignant disease.
- Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes.
- History of tendency to produce hypertrophic scars or keloids.
- Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms.
- Active infection within the last 30 days.
- Pregnant or nursing women.
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- Connective tissue disease.
- 'Lupus disease' defined as Systemic Lupus Erythematous or Discoid Lupus, or scleroderma defined as Progressive Systemic Sclerosis per history.
- Chronically treated with steroids or steroid therapy in a 3month period before surgery.
- Demonstrate psychological characteristics, which, in the opinion of the Investigator and/or consulting physician(s) are incompatible with the risks, involved with the surgical procedure, prosthesis and compliance with follow-up recommendations.
- Past or current capsular contracture defined as Baker III or IV.
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label, Single Arm, Multicenter Study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
Read the detailed description
This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex.
The study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.
- Being tested
- FixNip™ NRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FixNip™ NRIDevice
The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition
| Study group | Role | What they receive |
|---|---|---|
| Implantation of FixNip™ NRI | Experimental | Female Patients Seeking Reconstructive Surgery of the Nipple Receives: Device: FixNip™ NRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported
Measured: 12 months
Secondary outcomes (1)
Nipple Projection
Nipple projection in millimeter (mm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start6 Oct 2020
- Primary completion13 Jul 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of the Breast Nipple and Areola ComplexStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The sample size will be 10 female subjects undergoing reconstruction of the nipple, S/P breast reconstruction surgery as a result of breast cancer.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- FixNip Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Scheflan, MD, Principal investigator, Assuta MCAriel Tessone, MD, Study director, Sheba MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051892
- Sponsor's protocol ID
- CLN003_0100
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2019
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Single Arm, Multicenter Study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
- ClinicalTrials.gov ID
- NCT04051892
- Acronym / sponsor ID
- CLN003_0100
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FixNip LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 9 Aug 2019 (actual)
- 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.
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
Detailed description
This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex.
The study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample size will be 10 female subjects undergoing reconstruction of the nipple, S/P breast reconstruction surgery as a result of breast cancer.
| Arm | Type | Receives |
|---|---|---|
| Implantation of FixNip™ NRI | Experimental | Device: FixNip™ NRIFemale Patients Seeking Reconstructive Surgery of the Nipple |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women between the ages of 22-70 years.
- Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study.
- History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex.
- At least 3 months post breast reconstruction surgery.
- Baker scale grade I or II capsular contracture.
Key exclusion criteria (12 listed)
- Active malignant disease.
- Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes.
- History of tendency to produce hypertrophic scars or keloids.
- Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms.
- Active infection within the last 30 days.
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 |
|---|---|---|
| FixNip™ NRIThe FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition | Device | Implantation of FixNip™ NRI |
Primary outcome
Adverse event
Time frame: 12 months
Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported
1 secondary outcome
Nipple Projection
Time frame: 12 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 21 Mar 2023.
Related trials for Reconstruction of the Breast Nipple and Areola Complex
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RecruitingObservational study
BIOCHROMADERM® PMCF STUDY
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
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Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Mastectomy, Breast Reconstruction
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.
Michael Scheflan, MD principal investigator
Assuta MC
Ariel Tessone, MD study director
Sheba MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FixNip™ NRI in people with Reconstruction of the Breast Nipple and Areola Complex, run by FixNip Ltd 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 10 inclusion and 12 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 21 Mar 2023. 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.
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?
Adverse event (time frame: 12 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 21 Mar 2023.