Nipple-sparing MastectomyNCT05448963
Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
A study testing da Vinci SPⓇ Single-port System in people with Nipple-sparing Mastectomy and Prophylactic Mastectomy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer
- What is being tested?
- da Vinci SPⓇ Single-port System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2022to 1 Aug 2023
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with unilateral or bilateral breast cancer, including invasive and noninvasive carcinoma, eligible for unilateral or bilateral nipple-sparing mastectomy (NSM), either for therapeutic or prophylactic purpose, followed by immediate breast reconstruction.
- Meet at least one of the following indications of NSM for breast cancer:
- Preoperative clinical tumor sizes less than 5 cm, with adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image
- Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meet criteria a.
- Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure
- Age equal to or above 20 years
Show all 9Show fewer
- ECOG (Eastern Cooperative Oncology Group) performance score 0-1
- ASA anesthesia risk class 1~2, and with adequate organ functions
- Understanding of the method, benefit and risk and willing to receive immediate breast reconstruction
Who cannot join
- Extensive breast skin or nipple involvement by cancer including 1) Paget's disease, 2) nipple discharge associated with malignancy, 3) image findings suggesting involvement of the nipple and subareolar tissues 4) inflammatory breast cancer or skin ulceration caused by cancer invasion
- Stage III (up to T3, N1-2) breast cancer without response to neoadjuvant treatment
- Previous radiotherapy on the surgical site of breast
- Patients with severe systemic disease reaching ASA (American Society of Anesthesiologists) physical status classification equal or greater than 3
- Patients with bleeding disorder or coagulopathy
- Patients with BMI 35.0 or higher
- Patients with habitual smoking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Robot-assisted Nipple-sparing Mastectomy Followed by Immediate Breast Reconstruction Using da Vinci SP ® Single-port System
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the nipple areolar level. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which is likely to improve the efficacy of robotic mastectomy. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. Participants with breast cancer indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations are recruited to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility, and the secondary endpoint is safety and patient-reported outcome.
Read the detailed description
About 49% of breast cancer surgery is managed by total mastectomy, and half of the patients undergo breast reconstruction. Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. The local recurrence rate is not increased and the cosmetic result much improved. Robot-assisted mastectomy utilizes surgeon-controlled robotic arms with delicate, multi-jointed instruments and 3-dimentional high-definition camera in place of conventional instruments under bare eye vision. Through a single longitudinal incision in the anterior axillary line at the nipple areolar level, the lesion and the whole breast tissue can be totally removed with negative resection margins and well-preserved breast skin envelope. Breast reconstruction can be successfully performed through the same incision and results in a scarless front view. Currently, this surgery is effectively carried out with da Vinci Xi system. However, the small incision may result in the collision of robotic arms outside the torso and hence decreases the range of instrument motion. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which are devoid of outside collision and allows work in a larger surgical field through the same small incision. The SP system reduces blind areas in the surgical field and the blockade of camera vision by the detached space-taking specimens, and, therefore, will hopefully reduce the surgical time. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. The investigators recruit breast cancer women indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility (conversion rate, surgical time), and the secondary endpoint is safety and patient-reported outcome.
- Conditions
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- da Vinci SPⓇ Single-port System
- Keywords
- robotic mastectomy, robot-assisted mastectomy, nipple-sparing mastectomy, axillary lymph node dissection, breast cancer surgery, breast reconstruction, prophylactic mastectomy, single-port systems
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci SPⓇ Single-port SystemDevice
Nipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system
| Study group | Role | What they receive |
|---|---|---|
| Robotic mastectomy | Experimental | Patients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection Receives: Device: da Vinci SPⓇ Single-port System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical performance
Ability in percentage to complete nipple-sparing mastectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion) in per protocol population
Measured: Day 1
Secondary outcomes (2)
Incidence of Treatment-Emergent Acute Complications
Rate of incidence of surgery-related acute complications including hemorrhage, infection, skin ischemia, nipple ischemia, flap ischemia, and requirement for debridement or re-operation within 30 days
Measured: Day 1-Day 30
Incidence of Treatment-Emergent Mortality and Morbidity
Morbidity and mortality rate resulting from surgery among per protocol population
Measured: Day 1-Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Nipple-sparing MastectomyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- single arm surgical intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Principal investigator, KUO, WEN-LING, Chang Gung Memorial Hospital
- Investigators
- Wen-Ling Kuo, MD. PhD., Principal investigator, Breast Cancer Center, Chang Gone Memorial Hospital , Linkou Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448963
- Sponsor's protocol ID
- 202101421A0
- Status last verified
- Apr 2023
- First submitted
- 18 Jun 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD are to be shared upon request to the principle investigator. The content of data sharing depend on research relevance and cooperative detail.
Publications
Sarfati B, Toesca A, Roulot A, Invento A. Transumbilical Single-port Robotically Assisted Nipple-sparing Mastectomy: A Cadaveric Study. Plast Reconstr Surg Glob Open. 2020 May 27;8(5):e2778. doi: 10.1097/GOX.0000000000002778. eCollection 2020 May.
PubMed 33133886Park HS, Lee J, Lee H, Lee K, Song SY, Toesca A. Development of Robotic Mastectomy Using a Single-Port Surgical Robot System. J Breast Cancer. 2020 Feb;23(1):107-112. doi: 10.4048/jbc.2020.23.e3.
PubMed 32140275Garcia-Etienne CA, Cody Iii HS 3rd, Disa JJ, Cordeiro P, Sacchini V. Nipple-sparing mastectomy: initial experience at the Memorial Sloan-Kettering Cancer Center and a comprehensive review of literature. Breast J. 2009 Jul-Aug;15(4):440-9. doi: 10.1111/j.1524-4741.2009.00758.x. Epub 2009 May 22.
PubMed 19496781Galimberti V, Vicini E, Corso G, Morigi C, Fontana S, Sacchini V, Veronesi P. Nipple-sparing and skin-sparing mastectomy: Review of aims, oncological safety and contraindications. Breast. 2017 Aug;34 Suppl 1(Suppl 1):S82-S84. doi: 10.1016/j.breast.2017.06.034. Epub 2017 Jun 30.
PubMed 28673535Shimo A, Tsugawa K, Tsuchiya S, Yoshie R, Tsuchiya K, Uejima T, Kojima Y, Shimo A, Hayami R, Nishikawa T, Yabuki Y, Kawamoto H, Sudo A, Fukuda M, Kanemaki Y, Maeda I. Oncologic outcomes and technical considerations of nipple-sparing mastectomies in breast cancer: experience of 425 cases from a single institution. Breast Cancer. 2016 Nov;23(6):851-860. doi: 10.1007/s12282-015-0651-6. Epub 2015 Oct 13.
PubMed 26464007Frey JD, Salibian AA, Levine JP, Karp NS, Choi M. Incision Choices in Nipple-Sparing Mastectomy: A Comparative Analysis of Outcomes and Evolution of a Clinical Algorithm. Plast Reconstr Surg. 2018 Dec;142(6):826e-835e. doi: 10.1097/PRS.0000000000004969.
PubMed 30204677Daar DA, Abdou SA, Rosario L, Rifkin WJ, Santos PJ, Wirth GA, Lane KT. Is There a Preferred Incision Location for Nipple-Sparing Mastectomy? A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2019 May;143(5):906e-919e. doi: 10.1097/PRS.0000000000005502.
PubMed 30789474Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.
PubMed 28692558Selber JC. Robotic Nipple-Sparing Mastectomy: The Next Step in the Evolution of Minimally Invasive Breast Surgery. Ann Surg Oncol. 2019 Jan;26(1):10-11. doi: 10.1245/s10434-018-6936-1. Epub 2018 Nov 12. No abstract available.
PubMed 30421063Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
PubMed 27810700Lai HW, Wang CC, Lai YC, Chen CJ, Lin SL, Chen ST, Lin YJ, Chen DR, Kuo SJ. The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Eur J Surg Oncol. 2019 Feb;45(2):125-133. doi: 10.1016/j.ejso.2018.09.021. Epub 2018 Oct 17.
PubMed 30360987Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
PubMed 29484564Lai HW, Toesca A, Sarfati B, Park HS, Houvenaeghel G, Selber JC, Cheng FT, Kuo WL, Peradze N, Song SY, Mok CW. Consensus Statement on Robotic Mastectomy-Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019. Ann Surg. 2020 Jun;271(6):1005-1012. doi: 10.1097/SLA.0000000000003789.
PubMed 31977514Kuo WL, Huang JJ, Huang YT, Chueh LF, Lee JT, Tsai HP, Chen SC. Robot-assisted Mastectomy Followed by Immediate Autologous Microsurgical Free Flap Reconstruction: Techniques and Feasibility in Three Different Breast Cancer Surgical Scenarios. Clin Breast Cancer. 2020 Feb;20(1):e1-e8. doi: 10.1016/j.clbc.2019.06.018. Epub 2019 Sep 4. No abstract available.
PubMed 31780382Toesca 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 34597010
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Robot-assisted Nipple-sparing Mastectomy Followed by Immediate Breast Reconstruction Using da Vinci SP ® Single-port System
- ClinicalTrials.gov ID
- NCT05448963
- Acronym / sponsor ID
- 202101421A0
- Conditions
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Keywords
- robotic mastectomy, robot-assisted mastectomy, nipple-sparing mastectomy, axillary lymph node dissection, breast cancer surgery, breast reconstruction, prophylactic mastectomy, single-port systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 8 Jul 2022 (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.
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. Robot-assisted mastectomy enables removal of the whole breast tissue with well-preserved breast skin envelope through a single longitudinal incision in the anterior axillary line at the nipple areolar level. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which is likely to improve the efficacy of robotic mastectomy. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. Participants with breast cancer indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations are recruited to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility, and the secondary endpoint is safety and patient-reported outcome.
Detailed description
About 49% of breast cancer surgery is managed by total mastectomy, and half of the patients undergo breast reconstruction. Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer. The local recurrence rate is not increased and the cosmetic result much improved. Robot-assisted mastectomy utilizes surgeon-controlled robotic arms with delicate, multi-jointed instruments and 3-dimentional high-definition camera in place of conventional instruments under bare eye vision. Through a single longitudinal incision in the anterior axillary line at the nipple areolar level, the lesion and the whole breast tissue can be totally removed with negative resection margins and well-preserved breast skin envelope. Breast reconstruction can be successfully performed through the same incision and results in a scarless front view. Currently, this surgery is effectively carried out with da Vinci Xi system. However, the small incision may result in the collision of robotic arms outside the torso and hence decreases the range of instrument motion. The next-generation robot, da Vinci SP system, is single-armed, equipped with multiple flexible instruments and camera, which are devoid of outside collision and allows work in a larger surgical field through the same small incision. The SP system reduces blind areas in the surgical field and the blockade of camera vision by the detached space-taking specimens, and, therefore, will hopefully reduce the surgical time. The investigator's scope of this study is to establish the feasibility and safety of SP-applied NSM through this single-armed pilot trial. The investigators recruit breast cancer women indicated for nipple-sparing mastectomy or candidates of prophylactic mastectomy carrying germline pathogenic or likely pathogenic BRCA1/2 mutations to receive SP-assisted unilateral or bilateral NSMs. Immediate breast reconstruction is followed according to the mode of the plastic surgeon's clinical decision. The primary endpoint is technical feasibility (conversion rate, surgical time), and the secondary endpoint is safety and patient-reported outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm surgical intervention
| Arm | Type | Receives |
|---|---|---|
| Robotic mastectomy | Experimental | Device: da Vinci SPⓇ Single-port SystemPatients receive unilateral or bilateral robot-assisted nipple-sparing mastectomy with or without axillary lymph node dissection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women with unilateral or bilateral breast cancer, including invasive and noninvasive carcinoma, eligible for unilateral or bilateral nipple-sparing mastectomy (NSM), either for therapeutic or prophylactic purpose, followed by immediate breast reconstruction.
Key exclusion criteria (8 listed)
- Extensive breast skin or nipple involvement by cancer including 1) Paget's disease, 2) nipple discharge associated with malignancy, 3) image findings suggesting involvement of the nipple and subareolar tissues 4) inflammatory breast cancer or skin ulceration caused by cancer invasion
- Stage III (up to T3, N1-2) breast cancer without response to neoadjuvant treatment
- Previous radiotherapy on the surgical site of breast
- Patients with severe systemic disease reaching ASA (American Society of Anesthesiologists) physical status classification equal or greater than 3
- Patients with bleeding disorder or coagulopathy
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 |
|---|---|---|
| da Vinci SPⓇ Single-port SystemNipple-sparing mastectomy with or without axillary lymph node dissection using da Vinci SP single-port system | Device | Robotic mastectomy |
Primary outcome
Surgical performance
Time frame: Day 1
Ability in percentage to complete nipple-sparing mastectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion) in per protocol population
2 secondary outcomes
Incidence of Treatment-Emergent Acute Complications
Time frame: Day 1-Day 30
Incidence of Treatment-Emergent Mortality and Morbidity
Time frame: Day 1-Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 33133886Sarfati B, Toesca A, Roulot A, Invento A. Transumbilical Single-port Robotically Assisted Nipple-sparing Mastectomy: A Cadaveric Study. Plast Reconstr Surg Glob Open. 2020 May 27;8(5):e2778. doi: 10.1097/GOX.0000000000002778. eCollection 2020 May.
- Background: PubMed 32140275Park HS, Lee J, Lee H, Lee K, Song SY, Toesca A. Development of Robotic Mastectomy Using a Single-Port Surgical Robot System. J Breast Cancer. 2020 Feb;23(1):107-112. doi: 10.4048/jbc.2020.23.e3.
- Background: PubMed 19496781Garcia-Etienne CA, Cody Iii HS 3rd, Disa JJ, Cordeiro P, Sacchini V. Nipple-sparing mastectomy: initial experience at the Memorial Sloan-Kettering Cancer Center and a comprehensive review of literature. Breast J. 2009 Jul-Aug;15(4):440-9. doi: 10.1111/j.1524-4741.2009.00758.x. Epub 2009 May 22.
- Background: PubMed 28673535Galimberti V, Vicini E, Corso G, Morigi C, Fontana S, Sacchini V, Veronesi P. Nipple-sparing and skin-sparing mastectomy: Review of aims, oncological safety and contraindications. Breast. 2017 Aug;34 Suppl 1(Suppl 1):S82-S84. doi: 10.1016/j.breast.2017.06.034. Epub 2017 Jun 30.
- Background: PubMed 26464007Shimo A, Tsugawa K, Tsuchiya S, Yoshie R, Tsuchiya K, Uejima T, Kojima Y, Shimo A, Hayami R, Nishikawa T, Yabuki Y, Kawamoto H, Sudo A, Fukuda M, Kanemaki Y, Maeda I. Oncologic outcomes and technical considerations of nipple-sparing mastectomies in breast cancer: experience of 425 cases from a single institution. Breast Cancer. 2016 Nov;23(6):851-860. doi: 10.1007/s12282-015-0651-6. Epub 2015 Oct 13.
- Background: PubMed 30204677Frey JD, Salibian AA, Levine JP, Karp NS, Choi M. Incision Choices in Nipple-Sparing Mastectomy: A Comparative Analysis of Outcomes and Evolution of a Clinical Algorithm. Plast Reconstr Surg. 2018 Dec;142(6):826e-835e. doi: 10.1097/PRS.0000000000004969.
- Background: PubMed 30789474Daar DA, Abdou SA, Rosario L, Rifkin WJ, Santos PJ, Wirth GA, Lane KT. Is There a Preferred Incision Location for Nipple-Sparing Mastectomy? A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2019 May;143(5):906e-919e. doi: 10.1097/PRS.0000000000005502.
- Background: PubMed 28692558Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.
- Background: PubMed 30421063Selber JC. Robotic Nipple-Sparing Mastectomy: The Next Step in the Evolution of Minimally Invasive Breast Surgery. Ann Surg Oncol. 2019 Jan;26(1):10-11. doi: 10.1245/s10434-018-6936-1. Epub 2018 Nov 12. No abstract available.
- Background: PubMed 27810700Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
- Background: PubMed 30360987Lai HW, Wang CC, Lai YC, Chen CJ, Lin SL, Chen ST, Lin YJ, Chen DR, Kuo SJ. The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Eur J Surg Oncol. 2019 Feb;45(2):125-133. doi: 10.1016/j.ejso.2018.09.021. Epub 2018 Oct 17.
- Background: PubMed 29484564Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
- Individual participant dataSharing planned: No. IPD are to be shared upon request to the principle investigator. The content of data sharing depend on research relevance and cooperative detail.
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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.
Wen-Ling Kuo, MD. PhD. principal investigator
Breast Cancer Center, Chang Gone Memorial Hospital , Linkou Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci SPⓇ Single-port System in people with Nipple-sparing Mastectomy and Prophylactic Mastectomy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 9 inclusion and 8 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 25 Apr 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 Taiwan. 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?
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?
Surgical performance (time frame: Day 1). 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 NCT05448963, which also lists 19 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 25 Apr 2023.