Clinical trial NCT05245812: Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Official title: Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
High Risk of Breast Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer.

Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

Detailed description: rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction.

Investigational Device:

The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

Indications for Use:

The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.

Eligibility criteria: Inclusion Criteria:

* Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant or nursing women
* Patients with:
* Inflammatory breast cancer
* Skin involvement with tumor
* Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement
* Grade 3 or higher nipple ptosis
* Contraindicated for general anesthesia or surgery
* Heavy current smoking history (defined as \> 20 cigarettes per day)

Primary outcomes:
measure: Number of participants who complete single port nipple sparing mastectomy (SPrNSM)
timeFrame: Date of surgery (Day 1)
measure: Incidence of perioperative complications
timeFrame: 30 days following surgery
Secondary outcomes:
measure: Number of participants with positive margins
timeFrame: 2 weeks following date of surgery
measure: Number of participants with new breast cancers
timeFrame: following date of surgery up to 5 years
measure: Number of participants with recurrent breast cancers
timeFrame: following date of surgery up to 5 years
measure: Patient satisfaction as measured by BREAST-Q reconstruction tool
timeFrame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years
measure: Patient satisfaction as measured by BREAST-Q sensation tool
timeFrame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years
measure: Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline
timeFrame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years
measure: Incidence of short term complications
timeFrame: Post-operatively at 30 days
measure: Incidence of long term complications
timeFrame: Following surgery up to 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Deborah Farr, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: