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Procedure

Robot-assisted Surgery for Breast Cancer

N/A
Waitlist Available
Led By William Carson, MD
Research Sponsored by Ko Un Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing whether a robot-assisted surgery is safe and effective for breast cancer patients, and what risks it may pose.

Who is the study for?
This trial is for individuals who are candidates for nipple sparing mastectomy or preventive mastectomy due to breast cancer risk. Eligible participants must have a good performance status, meaning they can carry out daily activities with little or no assistance. It's not suitable for pregnant/nursing women, those with large breasts (over C cup), heavy smokers, or anyone with certain complications like severe nipple sagging, previous chest radiation, or tumor involvement in the nipple area.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of using a robotic system called daVinci for performing nipple sparing mastectomies in patients with breast cancer. The goal is to see if this high-tech method could be an alternative to traditional surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with surgeries may include infection at the incision site, bleeding, pain and discomfort post-operation. There might also be unique risks related to robot-assisted surgery such as technical difficulties during operation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication rate of patients with Mastectomy flap (SKIN flap score)
Complication rate of patients with bleeding requiring re-operation
Complication rate of patients with infection requiring antibiotics or re-operation
+4 more
Secondary outcome measures
Patient Reported Outcomes
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (RNSM, surveys)Experimental Treatment3 Interventions
RNMS Surveys

Find a Location

Who is running the clinical trial?

Ko Un ParkLead Sponsor
William CarsonLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
William Carson, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
5 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Breast Cancer
99 Patients Enrolled for Breast Cancer

Media Library

Robot-assisted Nipple Sparing Mastectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04537312 — N/A
~0 spots leftby Dec 2024
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