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NCT07528638 · ClinicalTrials.gov registry record · NA

Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)

A NA study, sponsored by University of Cincinnati.

Recruiting
Registry status
NA
Development phase
6
Enrollment target

NCT07528638: Recruiting NA study, sponsored by University of Cincinnati.

NCT07528638 is a NA study that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07528638, a NA study, is actively recruiting participants, sponsored by University of Cincinnati.

RECRUITING
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the implementation of existing neurosurgical techniques of intraoperative neuromonitoring (IONM) and the replacement of monopolar electrocautery with bipolar electrocautery (BE), during ALND, will improve the early identification of nerves that have been implicated in the cause of neuropathically-mediated post-surgical pain syndrome (PSPS).

Primary Outcome

The median and ulnar nerves will be stimulated at the beginning and throughout surgeryt. SSEPs will be recorded to ensure that the subject's nerves are appropriately responding to stimulation and that responses are similar to knwon parameters. The stimulating current and SSEP responses for N9 (brachial plexus), Cervical spine, and N20 (cortical) must be present and within acceptable levels (15%) of expected responses. A list of all stimulation parameters and corresponding SSEPs for the median an

Interventions

  • PROCEDURE IONM procedure

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2026-06-29
Est. Completion 2027-12-01
Phase NA
University of Cincinnati

245 total trials

What NCT07528638 shows while recruiting

NCT07528638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which IONM procedure is the first listed.

NCT07528638 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07528638 about?

NCT07528638 is a clinical study titled "Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND)". The purpose of this study is to determine whether the implementation of existing neurosurgical techniques of intraoperative neuromonitoring (IONM) and the replacement of monopolar electrocautery with bipolar electrocautery (BE), during ALND, will improve the early identification of nerves that have ...

What is the current status of trial NCT07528638?

This trial is currently recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2026-06-29. Estimated completion is 2027-12-01.

What interventions are being tested in trial NCT07528638?

The interventions under investigation include: IONM procedure (PROCEDURE).

Who is sponsoring clinical trial NCT07528638?

This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07528638's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT07528638, the US trial registry maintained by the National Library of Medicine. NCT07528638 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.