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NCT04537312 · ClinicalTrials.gov registry record · NA
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
A NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04537312: Active NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
NCT04537312 is a NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is active but no longer recruiting, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04537312, a NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Ohio State University Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Measure number of patients who had breast removed en bloc through RNSM incision.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What the registry record for NCT04537312 still lists
NCT04537312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 356-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (99% lower).
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.
NCT04537312 reports a single indexed study location in Ohio.
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.
What interventions are being tested in trial NCT04537312?
The interventions under investigation include: Survey Administration (OTHER), Robot-assisted Nipple Sparing Mastectomy (PROCEDURE), RNSM (DEVICE).
Who is sponsoring clinical trial NCT04537312?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Anatomic Stage II Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04537312's enrollment target sits among peer trials
4 74th of 73 the lowest of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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