Condition: Breast Cancer Classified as TNM Stage 0-IIIa · Sponsor: Yonsei University
Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction (IBR) conducted in conjunction with robot-assisted nipple-sparing mastectomy (RNSM). Study Design Overview This study is a prospective, multicenter, randomized clinical trial (ROM Trial) designed to compare the oncologic outcomes of robot-assisted nipple-sparing mastectomy (RNSM) with conventional nipple-sparing mastectomy (CNSM), which includes both traditional and open-chest approaches. Previous retrospective studies of robot-assisted endoscopic surgery have suggested a short learning curve, demonstrating technical feasibility and reproducibility even for less experienced surgeons. However, the absence of rigorously designed randomized clinical trials remains a major global barrier to the broader adoption of robotic breast surgery. In the ROM Trial, eligible patients who provide written informed consent will be randomly assigned in a 1:1 ratio to undergo either RNSM or CNSM. Participants will be blinded to group allocation until the day of surgery (single-blind design). Immediate breast reconstruction (IBR) will be performed in all patients, with the reconstruction method determined in consultation with the breast and/or plastic surgeon following mastectomy.
This description comes directly from the study's public registry record.
Hyung Seok Park, MD, PhD · 82-10-6760-2974 · imgenius@yuhs.ac
Always discuss trial participation with your own doctor first.
| Samsung Changwon Medical Center | Changwon, South Korea | Recruiting |
| Keimyung University Dongsan Hospital | Daegu, South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital | Daegu, South Korea | Recruiting |
| Yeungnam University Medical Center | Daegu, South Korea | Not Yet Recruiting |
| Myongji Hospital | Goyang-si, South Korea | Recruiting |
| The Catholic University of Korea, Incheon ST. Mary's Hospital | Incheon, South Korea | Recruiting |
| Kosin University Gospel Hospital | Pusan, South Korea | Recruiting |
| Chungnam National University Sejong Hospital | Sejong, South Korea | Not Yet Recruiting |
| Asan Medical Center | Seoul, South Korea | Not Yet Recruiting |
| Gangnam Severance Hospital | Seoul, South Korea | Not Yet Recruiting |
| Korea University Anam Hospital | Seoul, South Korea | Recruiting |
| Korea University Ansan Hospital | Seoul, South Korea | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05490433