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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaging in this research project?

"That is accurate. As observed on clinicaltrials.gov, this medical trial has been recruiting participants since November 17th 2020 and was last modified on May 9th 2022. The research team seeks to enrol 20 individuals at a single site."

Answered by AI

Is enrollment still open for this experiment?

"Correct. According to clinicaltrials.gov, this research is actively recruiting patients who were initially identified on November 17th 2020 and last updated on May 9th 2022. Approximately 20 individuals are being sought across 1 medical facility."

Answered by AI

Recent research and studies

BMJ OpenJournal

Prospective Pilot Study Protocol Evaluating the Safety and Feasibility of Robot-assisted Nipple-sparing Mastectomy (RNSM)

Park, Ko Un, Sandy Lee, Angela Sarna, Matthew Chetta, Steven Schulz, Doreen Agnese, Valerie Grignol, William E Carson, and Roman J Skoracki. 2021. “Prospective Pilot Study Protocol Evaluating the Safety and Feasibility of Robot-assisted Nipple-sparing Mastectomy (RNSM)”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-050173.

clinicaltrials.govStudy

Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

William Carson 2020. "Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04537312.