Transforaminal Lumbar Interbody Fusion SurgeryEARP-2NCT07020000
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
An observational study of Transforaminal Lumbar Interbody Fusion Surgery, run by Retropsoas Technologies, LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Transforaminal Lumbar Interbody Fusion Surgery
- What is being tested?
- Device: Nerve Cuff and Retractor System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Oct 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient undergoing LIF between L2-S1and surgeon feels is a good candidate for the EARP Procedure
Who may be able to join
- Undergoing LIF between L2-S1
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bryan Head of Clinical Affairs, PhD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Texas Orthopedic Hospital
Houston, Texas, 77030
Corey Hyrc, PhD, 713-347-9087, Corey.Hryc@Fondren.com
Andre Samuel, MD
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Adrienne Study Cooridinator, 904-953-5544, Graham.Adrienne@mayo.edu
Stephen Pirris, MD
- Not yet recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Thema Richardson, (267) 339-3615, Thema.Nicholson@rothmanortho.com
- Recruiting
Alleghany Health Network
Pittsburgh, Pennsylvania, 15212
Sarah Kilmutis, 412-359-3565, sarah.kimutis@ahn.org
Alex Yu, MD
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Linda Research Coordinator, 314-362-7368, koesterl@wustl.edu
About this study
Official title: A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
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.
Read the detailed description
This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.
- Being tested
- Device: Nerve Cuff and Retractor System
- Keywords
- Transforaminal Lumbar Interbody Fusion Surgery, TLIF, EARP, Retropsoas Technologies, LLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Nerve Cuff and Retractor SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measurements prior to surgery and at follow-up visits
Radiographic measurements including X-Ray, CT Scans, and MRIs if available
Measured: 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
Adverse Device Events and surgical complications due to the devices
Measured: From surgery until the end of follow up at 12 months
Secondary outcomes (3)
Assess the ability of the EARP fusion system to reduce pain and restore function
The Oswestry Disability Index (ODI)
Measured: Baseline to final follow-up visit at 12 months
Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode
IONM data during surgical procedure
Measured: During Surgery
Quantify health economic factors associated with the EARP fusion system for LIF procedures
Health economic data including OR time, operative time, hospital length of stay, anesthetic technique, unilateral vs. bilateral fixation, bone graft choice
Measured: From surgery to end of follow up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start22 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transforaminal Lumbar Interbody Fusion SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retropsoas Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020000
- Sponsor's protocol ID
- EARP-2-1002
- Acronym
- EARP-2
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
- ClinicalTrials.gov ID
- NCT07020000
- Acronym / sponsor ID
- EARP-2 / EARP-2-1002
- Keywords
- Transforaminal Lumbar Interbody Fusion Surgery, TLIF, EARP, Retropsoas Technologies, LLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Retropsoas Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient undergoing LIF between L2-S1and surgeon feels is a good candidate for the EARP Procedure
Key inclusion criteria (1 listed)
- Undergoing LIF between L2-S1
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Nerve Cuff and Retractor SystemEndoscopic 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. | Device | – |
Primary outcome
Radiographic measurements prior to surgery and at follow-up visits
Time frame: From enrollment until the end of follow-up at 12 months
Radiographic measurements including X-Ray, CT Scans, and MRIs if available
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
Adverse Device Events and surgical complications due to the devices
3 secondary outcomes
Assess the ability of the EARP fusion system to reduce pain and restore function
Time frame: Baseline to final follow-up visit at 12 months
Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode
Time frame: During Surgery
Quantify health economic factors associated with the EARP fusion system for LIF procedures
Time frame: From surgery to end of follow up at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Head of Clinical Affairs, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transforaminal Lumbar Interbody Fusion Surgery, run by Retropsoas Technologies, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Medical Director, MD (618-402-0035, npoulos@retropsoas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.