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NCT06204900 · ClinicalTrials.gov registry record · NA
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
A NA study of Transforaminal Lumbar Interbody Fusion Surgery, sponsored by Retropsoas Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06204900: Recruiting NA study of Transforaminal Lumbar Interbody Fusion Surgery, sponsored by Retropsoas Technologies.
NCT06204900 is a NA study of Transforaminal Lumbar Interbody Fusion Surgery that is actively recruiting participants, run by Retropsoas Technologies. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06204900, a NA study of Transforaminal Lumbar Interbody Fusion Surgery, is actively recruiting participants, sponsored by Retropsoas Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery. The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor surgical and nerve monitoring tools will be used in addition to standard nerve monitoring tools during the surgery. The choice of standard nerve monitoring equipment is based on the decision of the surgeon and technologist and is not dictated by this study. These tools will be compared with regards to safety and ability to accurately monitor the nervous system during the surgery.
Primary Outcome
Adverse device effect (ADE) - Adverse event (AE) judged by the clinician related to the use of an investigational devices. This includes any AE resulting from insufficient or inadequate instructions for use or the deployment, implantation, installation, or operation, or any malfunctioning of the investigational devices and any event resulting from use error or from unintentional misuse of the investigational devices.
Conditions Studied
Interventions
- DEVICE Nerve Cuff and Retractor System
Study Locations (2)
Pennsylvania
- Rothman Orthopaedic Institute - Philadelphia
- Allegheny-Singer Research Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2025-07 |
| Phase | NA |
What NCT06204900 shows while recruiting
NCT06204900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Transforaminal Lumbar Interbody Fusion Surgery appearing as the primary indexed condition, and to 1 intervention - of which Nerve Cuff and Retractor System is the first listed.
NCT06204900 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06204900 about?
NCT06204900 is a clinical study titled "A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.". The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery. The Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and Retractor surgical and nerve monitoring...
What is the current status of trial NCT06204900?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-06-07. Estimated completion is 2025-07.
What conditions does trial NCT06204900 study?
This clinical trial studies the following conditions: Transforaminal Lumbar Interbody Fusion Surgery.
What interventions are being tested in trial NCT06204900?
The interventions under investigation include: Nerve Cuff and Retractor System (DEVICE).
Who is sponsoring clinical trial NCT06204900?
This trial is sponsored by Retropsoas Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06204900 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06204900's enrollment target sits among peer trials
30 1594th of 2000 higher than 299 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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