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ACTIVE NOT RECRUITING NA

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

NCT04537312 · View on ClinicalTrials.gov ↗

Study Summary

This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.

Interventions

  • OTHER Survey Administration
  • PROCEDURE Robot-assisted Nipple Sparing Mastectomy
  • DEVICE RNSM

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center — Columbus

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2020-11-17
Est. Completion 2026-10-31
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04537312

The ClinicalTrials.gov registry entry for NCT04537312 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions — of which Survey Administration is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04537312 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04537312 about?

NCT04537312 is a clinical study titled "Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)". This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.

What is the current status of trial NCT04537312?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 4 participants. The study started on 2020-11-17. Estimated completion is 2026-10-31.

What conditions does trial NCT04537312 study?

This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04537312?

The interventions under investigation include: Survey Administration (OTHER), Robot-assisted Nipple Sparing Mastectomy (PROCEDURE), RNSM (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04537312?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04537312 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial