ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain (RENEU)

ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)

The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Greater Trochanteric Pain Syndrome; Lateral Hip Pain; Greater Trochanteric Pain Syndrome of Both Lower Limbs
• Intervention / Treatment: Drug: Triamcinolone acetate; Device: ReneuRx

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Curd; Phone Number: 314-480-2244; Email: david.curd@brixtonbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 22 to 80, inclusive of any gender
2. Baseline pain intensity of >5 of the Numeric Rating Scale (NRS) localized to the lateral aspect of the hip (with or without radiation to lateral thigh or buttock) despite current treatment
3. Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
4. At least 6 months of previous conservative treatments for subject's lateral hip pain (NSAID, acetaminophen, physical therapy, and/or cortisone injections) that are not currently providing relief
5. Agree to see study investigator and study team for hip pain during the study period
6. Willing/able to understand the informed consent form and provide written informed consent
7. Able to complete outcome measures (including electronic patient reported outcome measures)

Exclusion Criteria:

1. Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
2. History of cryoglobulinemia
3. History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
4. History of cold urticaria
5. History of Chilblain's (pernio) disease in the lower extremities
6. History of Raynaud's disease
7. Open and/or infected wounds or active tumor at or near the treatment site
8. History of vascular surgery involving femoral vessels on theinjection side
9. History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
10. History of trochanteric osteotomy, femoral osteotomy, or amputation
11. Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
12. Currently taking >60 MME/day
13. History of systemic inflammatory conditions such as rheumatoid arthritis
14. Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
15. Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain
16. Presence of unstable psychiatric disease
17. Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months
18. Corticosteroid injection within the previous 3 months or orthobiologic therapy such as platelet rich plasma injections for the index hip(s) within the previous 6 months
19. Known contraindication to use of a regional anesthetic block
20. Pregnant, nursing, or intent of becoming pregnant during the study period
21. Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain
22. Lumbar or sacroiliac fusion within the previous 6 months
23. Any other condition (such as history of deep vein thrombosis, significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition including cancer) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
24. Body habitus/hip anatomy that would preclude the use of the product injection needle size
25. Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
26. Pending litigation or disability status
27. Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study
28. Subject is a prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triamcinolone acetate; Corticosteroid injection	Drug: Triamcinolone acetate; A single dose of Triamcinolone 40mg injected directly into the hip joint.
Experimental: ReneuRx	Device: ReneuRx; ReneuRx will be injected around the trochanteric branches of the femoral nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness	The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment	3-months post treatment
Primary Safety	Aggregate serious device-related adverse events through final follow-up visit	Through study completion, an average of 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness	Numeric Rating Scales - The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. With 0 being no pain and 10 being the most pain.	Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness	Patient Global Impressions Scale (PGIC) The Patient Global Impression of Change (PGIC) score is a self-reported measure used to assess a patient's perception of their overall improvement or worsening in health status following a specific treatment. It is often used in clinical trials and research studies to gauge the efficacy of interventions from the patient's perspective. The PGIC typically ranges from "very much worse" to "very much improved".	3 month and 6 month post-treatment
Secondary Effectiveness	VISA-G (Victorian Institute of Sports Assessment-Gluteal Score) The Victorian Institute of Sport Assessment (VISA-) Gluteal (G) Questionnaire is a self-report clinical outcome measure used in patients with greater trochanteric pain syndrome (GTPS). It consists of eight questions that measure the domains of pain, function in daily living, and sports activities The VISA-G can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.	Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
Secondary Effectiveness	Change in Timed-Up and Go (TUG) test scores	12 months post-treatment
Pain Relief	Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.	6-Month, 12-Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint	Patient Specific Functional Scale (PSFS) The Patient-Specific Functional Scale (PSFS) assesses a subject's functional ability to complete an activity. Activities will be rated on an 11-point scale (0-10), where 0 indicates "unable to perform activity" and 10 indicates "able to perform activity at the same level as before injury or problem." The activities will be chosen and approved by both the subject and investigator.	12 months post-treatment
Exploratory Endpoints	Patient-Reported Outcome Measurement Information System (PROMIS) 29 score The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.	12 months post-treatment

Collaborators and Investigators

• Sponsor: Brixton Biosciences, Inc.
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GTPS; RENEU; ReneuRx™; ReneuRx
• Additional Relevant MeSH Terms: Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone
• Other Study ID Numbers: BTX-786-GTPS-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes