Breast ReconstructionReborn-iNCT07236359
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
A study testing Intervention and Standard open nipple sparing mastectomy with immediate implant-based reconstruction in people with Breast Reconstruction and Breast Cancer, run by Beaumont Hospital.
Trial summary
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
- What is being tested?
- Intervention and Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older
- Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications:
- Genetic mutation carriers undergoing risk-reducing mastectomy.
- Ductal carcinoma in situ (DCIS) requiring mastectomy.
- Early invasive breast cancer requiring mastectomy.
- The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).
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- Candidates for immediate breast reconstruction with IMPLANT reconstruction
- Fluent in English
- Fit for general anaesthetic
- Signed informed consent form
Who cannot join
- Advanced breast cancer with skin involvement.
- Nipple involvement for Nipple Sparing Mastectomy Arms.
- Prior chest wall radiation therapy
- Pregnancy
- Lactation
- Patients with insufficient English to sign an informed consent (i.e. interpreter required).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast.
However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.
Read more
This study will compare:
- Robotic nipple-sparing mastectomy
- Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.
Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Being tested
- Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionProcedure or surgery
Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
Standard open nipple sparing mastectomy with immediate implant-based reconstructionProcedure or surgery
Standard open nipple sparing mastectomy with immediate implant-based reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. | Experimental | Intervention Receives: Procedure: Intervention |
| Standard open nipple sparing mastectomy with immediate implant-based reconstruction. | Active comparator | Standard of care Receives: Procedure: Standard open nipple sparing mastectomy with immediate implant-based reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Outcome Measures
- Surgical complication rates within 30 and 90 days, classified according to the Clavien-Dindo system.
- Reoperation rates and need for unplanned return to theatre.
- Length of hospital stay and drain duration
- Operative time and estimated intraoperative blood loss.
- Time to return to daily activities including work and physical exercise.
- Aesthetic outcomes, assessed both by patient-reported satisfaction and by an independent panel review of standardized postoperative photographs.
- Oncologic outcomes, including final pathology margin status and local recurrence (if applicable during follow-up).
- Amount of residual breast tissue left on post operative MRI at 6 months in the different groups.
Measured: 1 year
Primary Outcome Measure
The primary endpoint of this study is the difference Breast Q scores at 12 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Arnold Hill, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236359
- Sponsor's protocol ID
- 25/72
- Acronym
- Reborn-i
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and anonymous study data will be shared through peer reviewed publication
Publications
Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.
PubMed 34597010Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18.
PubMed 29251382
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
- ClinicalTrials.gov ID
- NCT07236359
- Acronym / sponsor ID
- Reborn-i / 25/72
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Nov 2025 (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.
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast.
However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries.
This study will compare:
- Robotic nipple-sparing mastectomy
- Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients.
Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. | Experimental | Procedure: InterventionIntervention |
| Standard open nipple sparing mastectomy with immediate implant-based reconstruction. | Active comparator | Procedure: Standard open nipple sparing mastectomy with immediate implant-based reconstructionStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women aged 18 years and older
- Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications:
- Genetic mutation carriers undergoing risk-reducing mastectomy.
- Ductal carcinoma in situ (DCIS) requiring mastectomy.
- Early invasive breast cancer requiring mastectomy.
Key exclusion criteria (6 listed)
- Advanced breast cancer with skin involvement.
- Nipple involvement for Nipple Sparing Mastectomy Arms.
- Prior chest wall radiation therapy
- Pregnancy
- Lactation
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 |
|---|---|---|
| InterventionSingle-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. | Procedure or surgery | Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction. |
| Standard open nipple sparing mastectomy with immediate implant-based reconstructionStandard open nipple sparing mastectomy with immediate implant-based reconstruction | Procedure or surgery | Standard open nipple sparing mastectomy with immediate implant-based reconstruction. |
Primary outcome
Secondary Outcome Measures
Time frame: 1 year
* Surgical complication rates within 30 and 90 days, classified according to the Clavien-Dindo system. * Reoperation rates and need for unplanned return to theatre. * Length of hospital stay and drain duration * Operative time and estimated intraoperative blood loss. * Time to return to daily activities including work and physical exercise. * Aesthetic outcomes, assessed both by patient-reported satisfaction and by an independent panel review of standardized postoperative photographs. * Oncologic outcomes, including final pathology margin status and local recurrence (if applicable during follow-up). * Amount of residual breast tissue left on post operative MRI at 6 months in the different groups.
Primary Outcome Measure
Time frame: 1 year
The primary endpoint of this study is the difference Breast Q scores at 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 34597010Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.
- Background: PubMed 29251382Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18.
- Individual participant dataSharing planned: Yes. Protocol and anonymous study data will be shared through peer reviewed publication
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Standard open nipple sparing mastectomy with immediate implant-based reconstruction in people with Breast Reconstruction and Breast Cancer, run by Beaumont Hospital.
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 6 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trudi Roche Nelson, ANP RGN MSC (+35318093000, troche@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary Outcome Measures (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236359, which also lists 2 linked publications.
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 19 Nov 2025.