Degenerative SpondylolisthesisNCT03115983

LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

A study testing LimiFlex, Fusion Instrumentation and Decompression in people with Degenerative Spondylolisthesis and Lumbar Spinal Stenosis, run by Empirical Spine, Inc. at 28 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 25 to 80 years
Conditions the study is for: Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
What is being tested?: LimiFlex, Fusion Instrumentation and Decompression
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 28 sitesUnited States
Study dates: 17 Jul 2017to 16 Jan 2026
Phase: Interventional
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 25 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

A primary and predominate diagnosis of discogenic back pain;
A primary and predominate diagnosis of facet-mediated back pain;
Back or non-radicular leg pain of unknown etiology;
Significant peripheral vascular disease causing vascular claudication;
Significant peripheral neuropathy caused by conditions other than spinal stenosis;
History of fixed or permanent neurological deficit related to spinal cord injury;

Show all 42Show fewer

History of any previous surgery* at any level in the lumbosacral spine except for a discectomy or decompression;
History of any previous surgery* at the level planned for treatment;
previous surgery includes spinal stimulator placement but does NOT include epidural injections, rhizotomy or nerve ablation.
Isthmic spondylolisthesis or spondylolysis (pars fracture) at any level in the lumbar spine;
Clinically significant compromise of vertebrae at L1 to S1 levels due to osteoporotic vertebral compression fracture or any traumatic, neoplastic, metabolic or infectious pathology or congenital abnormality;
Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented that would preclude secure fixation of the LimiFlex Device to the spinous process;
Spinous process insufficiency or deformity that would preclude secure fixation of the LimiFlex Device to the spinous process including spinous process length <10 mm from lamina to dorsal tip or other significant deformity due to trauma, or congenital abnormality such as spina bifida occulta at the planned instrumented level that would preclude secure fixation of the LimiFlex Device to the spinous process;
The estimated distance between the LimiFlex Device strap attachment points (midpoint of the cranial edge of the cranial spinous process and the midpoint of the caudal edge of the caudal spinous process) is <30mm on pre-operative lateral standing radiographs at the segment to be instrumented;
Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment;
Symptomatic lumbar stenosis that is not amenable to a direct decompression
Anklyosed motion segment at the target operative level
Severe osteoporosis, defined as history of fragility fracture and DXA T-score <-2.5 or QCT T-score <80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed;
Planned hip or knee replacement surgery, severe osteoarthritis or other musculoskeletal pathology of the hip or leg that could preclude reliable patient self reporting assessment scales and/or that would likely progress to surgery during study period;
Documented allergy to titanium or polyethylene;
Active local or systemic infection;
Receiving immunosuppressive or long-term steroid therapy;
Known history of bone metabolic disorder, including Paget's disease, hyperparathyroidism, renal osteodystrophy, and osteomalacia;
Disease or condition that would preclude accurate clinical evaluation of the safety and effectiveness of the study treatment or any significant medical conditions which would place the patient at excessive risk for surgery, such as:
severe rheumatoid arthritis or other severe autoimmune disease
active hepatitis (viral or serum) or HIV positive
unstable cardiac disease
uncontrolled diabetes
renal failure
severe muscular, neural or vascular diseases that endanger the spinal column
cauda equina syndrome
severe neurologic disorders including paralysis
Morbid obesity defined as BMI >40;
Active malignancy or history of metastatic malignancy within the last five years;
Women who are pregnant or are interested in becoming pregnant within the study period;
Currently seeking or receiving worker's compensation for back pain or spinal condition;
Currently involved in spinal litigation that potentially is associated with secondary financial gain;
Current involvement in a study of another investigational product for similar purpose;
Demonstrates three or more Waddell's Signs of Inorganic Behavior;
Active treatment of a major psychiatric condition, such as major depression, anxiety disorder, bipolar disorder, schizophrenia, personality disorder, that could prevent accurate completion of self reporting assessment scales;
Current history (within 12 months) of substance abuse, including alcohol abuse; or
A prisoner.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Emory University
Atlanta, Georgia, 30329
UHS Neurosurgery (Binghamton)
Binghamton, New York, 13760
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Boulder Neurological & Spine Associates
Boulder, Colorado, 80303
Indiana Spine Group
Carmel, Indiana, 46032
University of Virginia Orthopaedic Surgery
Charlottesville, Virginia, 22908
Rush University
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43210
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
University of Miami, Dept of Neurological Surgery
Miami, Florida, 33136
Hospital for Special Surgery
New York, New York, 10022
Kaiser Permanente Division of Research
Oakland, California, 94611
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
Texas Back Institue, Clincal Research, LLC-Plano
Plano, Texas, 75093
Stanford University Medical Center
Redwood City, California, 94063
Beaumont Hospital
Royal Oak, Michigan, 48073
UC Davis Spine Center
Sacramento, California, 95816
Kaiser Permanente Roseville Clinical Trials Program
Sacramento, California, 95825
UCSF Dept of Orthopaedic Surgery
San Francisco, California, 94143
Kaiser Permanente (San Jose Medical Center)
San Jose, California, 95119
The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration
Santa Monica, California, 90403
Swedish Medical Center
Seattle, Washington, 98122
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13057
BioSpine
Tampa, Florida, 33607
Sonoran Spine Research and Education Foundation
Tempe, Arizona, 85281
Michigan Minimally Invasive Neurosurgical Institute
Waterford, Michigan, 48327
University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis

The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.

Read the detailed description

The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached to pedicle-sparing straps which encircle adjacent spinous processes.

Conditions: Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
Being tested: LimiFlex, Fusion Instrumentation, Decompression, Fusion
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LimiFlexDevice
Also called LimiFlex Paraspinous Tension Band
LimiFlex implantation at a single level after surgical decompression.
Fusion InstrumentationDevice
Titanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).
DecompressionProcedure or surgery
Surgical decompression at one or two contiguous levels from L1 to S1.
FusionProcedure or surgery
Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.

Study groups in NCT03115983
Study group	Role	What they receive
LimiFlex	Experimental	Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band Receives: Device: LimiFlex; Procedure: Decompression
Fusion	Active comparator	Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation Receives: Device: Fusion Instrumentation; Procedure: Decompression; Procedure: Fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Clinical Success
Individual success for patients in the investigational LimiFlex or control fusion arm is assessed with Composite Clinical Success (CCS) criteria. To be considered a success, a subject must demonstrate all of the following:
- 15 point improvement in Oswestry Disability Index (100 point scale)
- Absence of a new or worsening, persistent neurological deficit
- Absence of additional surgical intervention
- Absence of device integrity failures
Measured: 24 Months

Secondary outcomes (16)

Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Neurological Status
Neurological Status
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Additional surgical interventions
Additional surgical interventions
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Estimated blood loss
estimated blood loss and units of blood transfused
Measured: Procedure
Length of procedure
Length of procedure (skin to skin)
Measured: Procedure
Hospital stay
Hospital stay
Measured: Immediately upon discharge
Return to normal activities of daily living
Length of time for subject to return to his/her normal activities of daily living.
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Work status
Work status and days to return to work (as appropriate)
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Pain medication including narcotics usage
Medication use for pain, including narcotic, usage
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Visual analog scale (VAS) leg pain
Leg pain as measured on a Visual Analog Scale (VAS)
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Visual analog scale (VAS) back pain
Back pain as measured on a Visual Analog Scale (VAS)
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Zurich claudication questionnaire (ZCQ)
Zurich claudication questionnaire
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
SF-12 Quality of Life survey
SF-12 Health Survey
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Patient satisfaction
Patient satisfaction questionnaire
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Radiographic fusion status
Radiographic fusion status
Measured: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 201716 Jan 2026

First posted14 Apr 2017
Study start17 Jul 2017
Primary completion30 Dec 2025 (estimated)
Study completion16 Jan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Degenerative SpondylolisthesisStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is a multi-center, prospective, concurrently controlled, non-blinded study. Balance between groups will be achieved through sub classification using propensity scores. Prospective patient sample supplemented with retrospective and/or historical control subjects.
Masking: None (open label)
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03115983
Sponsor's protocol ID: LSS17001
Status last verified: Aug 2025
First submitted: 31 Mar 2017
Last updated: 7 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Maislin G, Keenan BT, Alamin TF, Fielding LC, Scherman A, Hachadoorian R, Pierre C, Sasso RC, Lavelle WF, Chapman J. Are Randomized Trials Better? Comparison of Baseline Covariate Balance of a Propensity Score-Balanced Lumbar Spine IDE Trial and Comparable RCTs. Global Spine J. 2025 Jul;15(6):2923-2930. doi: 10.1177/21925682251316287. Epub 2025 Jan 27.
PubMed 39868633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis

All Degenerative Spondylolisthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis
ClinicalTrials.gov ID: NCT03115983
Acronym / sponsor ID: LSS17001
Conditions: Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 299 participants (actual)
Lead sponsor: Empirical Spine, Inc.Industry (pharma, biotech, devices)
Collaborators: Biomedical Statistical Consulting, Medical Metrics Diagnostics, Inc, MCRA
Study start: 17 Jul 2017 (actual)
Primary completion: 30 Dec 2025 (estimated)
Study completion: 16 Jan 2026 (estimated)
First posted: 14 Apr 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a multi-center, prospective, concurrently controlled, non-blinded study. Balance between groups will be achieved through sub classification using propensity scores. Prospective patient sample supplemented with retrospective and/or historical control subjects.

Arm	Type	Receives
LimiFlex	Experimental	Device: LimiFlex, Procedure: DecompressionPosterior dynamic stabilization with the LimiFlex Paraspinous Tension Band
Fusion	Active comparator	Device: Fusion Instrumentation, Procedure: Decompression, Procedure: FusionTransforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation

Who may qualify

Ages: 25 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (42 listed)

A primary and predominate diagnosis of discogenic back pain;
A primary and predominate diagnosis of facet-mediated back pain;
Back or non-radicular leg pain of unknown etiology;
Significant peripheral vascular disease causing vascular claudication;
Significant peripheral neuropathy caused by conditions other than spinal stenosis;

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
LimiFlexAlso: LimiFlex Paraspinous Tension BandLimiFlex implantation at a single level after surgical decompression.	Device	LimiFlex
Fusion InstrumentationTitanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).	Device	Fusion
DecompressionSurgical decompression at one or two contiguous levels from L1 to S1.	Procedure or surgery	Fusion, LimiFlex
FusionTransforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.	Procedure or surgery	Fusion

Primary outcome

Composite Clinical Success
Time frame: 24 Months
Individual success for patients in the investigational LimiFlex or control fusion arm is assessed with Composite Clinical Success (CCS) criteria. To be considered a success, a subject must demonstrate all of the following: * 15 point improvement in Oswestry Disability Index (100 point scale) * Absence of a new or worsening, persistent neurological deficit * Absence of additional surgical intervention * Absence of device integrity failures

16 secondary outcomes

Oswestry Disability Index (ODI)
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Neurological Status
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Additional surgical interventions
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Estimated blood loss
Time frame: Procedure
Length of procedure
Time frame: Procedure
Hospital stay
Time frame: Immediately upon discharge
Return to normal activities of daily living
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Work status
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Pain medication including narcotics usage
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Visual analog scale (VAS) leg pain
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Visual analog scale (VAS) back pain
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Zurich claudication questionnaire (ZCQ)
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
SF-12 Quality of Life survey
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Patient satisfaction
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo
Radiographic fusion status
Time frame: Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

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 7 Aug 2025.
Derived from this study: PubMed 39868633Maislin G, Keenan BT, Alamin TF, Fielding LC, Scherman A, Hachadoorian R, Pierre C, Sasso RC, Lavelle WF, Chapman J. Are Randomized Trials Better? Comparison of Baseline Covariate Balance of a Propensity Score-Balanced Lumbar Spine IDE Trial and Comparable RCTs. Global Spine J. 2025 Jul;15(6):2923-2930. doi: 10.1177/21925682251316287. Epub 2025 Jan 27.
Individual participant dataSharing planned: No

Related trials for Degenerative Spondylolisthesis

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis

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. This study is not recruiting at the moment.

Rick Sasso, MD principal investigator

Indiana Spine Group

William C Welch, MD principal investigator

Pennsylvania Hospital Neurosurgery

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LimiFlex, Fusion Instrumentation and Decompression in people with Degenerative Spondylolisthesis and Lumbar Spinal Stenosis, run by Empirical Spine, Inc. at 28 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 0 inclusion and 42 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Clinical Success (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115983, which also lists 1 linked publication.

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 7 Aug 2025.