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NCT05245812 · ClinicalTrials.gov registry record · NA
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
A NA study of Breast Cancer and High Risk of Breast Cancer, sponsored by Deborah Farr, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05245812 is a NA study of Breast Cancer and High Risk of Breast Cancer that is actively recruiting participants, run by Deborah Farr, MD. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05245812, a NA study of Breast Cancer and High Risk of Breast Cancer, is actively recruiting participants, sponsored by Deborah Farr, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE da Vinci SP Surgical System
Study Locations (1)
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2027-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05245812
The ClinicalTrials.gov registry entry for NCT05245812 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Deborah Farr, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which da Vinci SP Surgical System is the first listed.
NCT05245812 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05245812 about?
NCT05245812 is a clinical study titled "Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy". 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 expander...
What is the current status of trial NCT05245812?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2022-03-08. Estimated completion is 2027-02.
What conditions does trial NCT05245812 study?
This clinical trial studies the following conditions: Breast Cancer, High Risk of Breast Cancer.
What interventions are being tested in trial NCT05245812?
The interventions under investigation include: da Vinci SP Surgical System (DEVICE).
Who is sponsoring clinical trial NCT05245812?
This trial is sponsored by Deborah Farr, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05245812 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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