Anatomic Stage IA Breast Cancer AJCC v8SPrNSMNCT04866992
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
An observational study of Anatomic Stage IA Breast Cancer AJCC v8 and Anatomic Stage IB Breast Cancer AJCC v8, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 24 Sep 2021
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.
Who may be able to join
- 1. Subjects age >= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Who cannot join
- Subjects who are <18 years of age
- Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
Read the detailed description
Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy.
Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Keywords
- Nipple Sparing Mastectomy, Robot-assisted Nipple Sparing Mastectomy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of completion of SPrNSM through axillary incision
Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision
Measured: Up to 1 year
Complication rate of patients requiring re-operation
Number of patients with bleeding requiring a second surgery after SPrNSM
Measured: Up to 1 year
Complication rate of patients with infection requiring explantation of tissue expander
Number of patients with infection after surgery requiring explantation of tissue expander
Measured: Up to 1 year
Complication rate of patients with mastectomy flap necrosis
number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score
Measured: Up to 1 year
Operative surgery time trends with peri-operative outcomes
Measure total surgery time in relation to other outcomes in each patient
Measured: Up to 1 year
Secondary outcomes (2)
Patient reported outcomes
Patient satisfaction is measured using BREAST-Q. Possible scores range from 1-10 Likert scale, with higher scores indicating better/ worse outcome.
Measured: Up to 1 year
Patient reported outcomes
Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Feb 2020
- Primary completion14 Jul 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IA Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Farr, University of Texas Southwestern Medical Center
- Investigators
- Deborah Farr, M.D., Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866992
- Sponsor's protocol ID
- STU-2019-0522
- Acronym
- SPrNSM
- Status last verified
- Jan 2022
- First submitted
- 1 Apr 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The study share data of individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
- ClinicalTrials.gov ID
- NCT04866992
- Acronym / sponsor ID
- SPrNSM / STU-2019-0522
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Keywords
- Nipple Sparing Mastectomy, Robot-assisted Nipple Sparing Mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 30 Apr 2021 (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 is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
Detailed description
Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy.
Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women who undergo robotic nipple sparing mastectomy (rNSM) with reconstruction.
Key inclusion criteria (1 listed)
- 1. Subjects age >= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Key exclusion criteria (2 listed)
- Subjects who are <18 years of age
- Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of completion of SPrNSM through axillary incision
Time frame: Up to 1 year
Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision
Complication rate of patients requiring re-operation
Time frame: Up to 1 year
Number of patients with bleeding requiring a second surgery after SPrNSM
Complication rate of patients with infection requiring explantation of tissue expander
Time frame: Up to 1 year
Number of patients with infection after surgery requiring explantation of tissue expander
Complication rate of patients with mastectomy flap necrosis
Time frame: Up to 1 year
number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score
Operative surgery time trends with peri-operative outcomes
Time frame: Up to 1 year
Measure total surgery time in relation to other outcomes in each patient
2 secondary outcomes
Patient reported outcomes
Time frame: Up to 1 year
Patient reported outcomes
Time frame: Up to 1 year
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 Jan 2022.
- Individual participant dataSharing planned: No. The study share data of individual participants.
Related trials for Anatomic Stage IA Breast Cancer AJCC v8
Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Active, not recruitingPhase 3
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
Recruiting
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Active, not recruiting
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
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.
Deborah Farr, M.D. principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage IA Breast Cancer AJCC v8 and Anatomic Stage IB Breast Cancer AJCC v8, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 1 inclusion and 2 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 Jan 2022. 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 United States. 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?
Feasibility of completion of SPrNSM through axillary incision (time frame: Up to 1 year). The study lists 5 primary outcomes in all. 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 Jan 2022.