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

NCT07568015 | Not Yet Recruiting FDA Device

• 1 other identifier: BTX-786-GTPS-02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Greater Trochanteric Pain Syndrome; Greater Trochanteric Pain Syndrome of Both Lower Limbs; Lateral Hip Pain

Keywords

RENEU; ReneuRx™; ReneuRx; GTPS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Secondary Effectiveness

  Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month

• Secondary Effectiveness

  3 month and 6 month post-treatment

• Secondary Effectiveness

  Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month

• Secondary Effectiveness

  12 months post-treatment

• Pain Relief

  6-Month, 12-Month

Other Outcomes (2)

• Exploratory Endpoint

  12 months post-treatment

• Exploratory Endpoints

  12 months post-treatment

Study Arms (2)

Triamcinolone acetate

ACTIVE COMPARATOR

Corticosteroid injection

Drug: Triamcinolone acetate

ReneuRx

EXPERIMENTAL

Device: ReneuRx

Interventions

Triamcinolone acetate DRUG

A single dose of Triamcinolone 40mg injected directly into the hip joint.

Triamcinolone acetate

ReneuRx DEVICE

ReneuRx will be injected around the trochanteric branches of the femoral nerve.

ReneuRx

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 80, inclusive of any gender
• 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
• Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
• 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
• Agree to see study investigator and study team for hip pain during the study period
• Willing/able to understand the informed consent form and provide written informed consent
• Able to complete outcome measures (including electronic patient reported outcome measures)

You may not qualify if:

• Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
• History of cryoglobulinemia
• History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
• History of cold urticaria
• History of Chilblain's (pernio) disease in the lower extremities
• History of Raynaud's disease
• Open and/or infected wounds or active tumor at or near the treatment site
• History of vascular surgery involving femoral vessels on theinjection side
• History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
• History of trochanteric osteotomy, femoral osteotomy, or amputation
• Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
• Currently taking \>60 MME/day
• History of systemic inflammatory conditions such as rheumatoid arthritis
• Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
• Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain

Sponsors & Collaborators

• Brixton Biosciences, Inc.: lead
• MCRA: collaborator

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

David Curd

CONTACT

314-480-2244; david.curd@brixtonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04