Recruiting

EARP Devices

Sponsor:

Retropsoas Technologies, LLC

Code:

NCT07020000

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Device: Nerve Cuff and Retractor System

Study Details

Brief summary:

The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.

The primary objectives are:

  • To evaluate the safety of the EARP surgical technique and devices during LIF surgeries.
  • To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.

Conditions

Transforaminal Lumbar Interbody Fusion Surgery

Study ID

NCT07020000

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing LIF between L2-S1

Exclusion Criteria:

  • BMI >40 kg/m2
  • Pregnant or plans on becoming pregnant in the near future
  • Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level
  • History of lumbar interbody pseudoarthrosis at planned operative level
  • Lumbar spondylolisthesis ≥ grade 3
  • Osteoporotic vertebral compression fracture treated or untreated at planned operative site
  • History of lumbar spinal metastasis
  • Acute lumbar spine trauma requiring immediate intervention
  • Owestry Disability Index (ODI) 81-100%
  • Presence of personality disorder or major psychiatric illness
  • History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone
  • Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Device: Nerve Cuff and Retractor System

Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system to safely monitor lumbar nerve root activity and function during standard interbody fusion surgeries.

Primary outcome measure

  • Radiographic measurements prior to surgery and at follow-up visits [ Time Frame: From enrollment until the end of follow-up at 12 months ]
  • To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries [ Time Frame: From surgery until the end of follow up at 12 months ]

Central Contacts and Locations

Central contacts

Nicholas Medical Director, MD

618-402-0035npoulos@retropsoas.com

Bryan Head of Clinical Affairs, PhD

7248777600

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Adrienne Study Cooridinator

904-953-5544Graham.Adrienne@mayo.edu

Principal Investigator:

Stephen Pirris, MD

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Linda Research Coordinator

314-362-7368koesterl@wustl.edu

Alleghany Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sarah Kilmutis

412-359-3565sarah.kimutis@ahn.org

Principal Investigator:

Alex Yu, MD

Texas Orthopedic Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Corey Hyrc, PhD

713-347-9087Corey.Hryc@Fondren.com

Principal Investigator:

Andre Samuel, MD

More Information

Sponsor

Retropsoas Technologies, LLC

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • Transforaminal Lumbar Interbody Fusion Surgery
  • TLIF
  • EARP
  • Retropsoas Technologies, LLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Retropsoas Technologies, LLC on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.