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

9. september 2026 oppdatert av: Brixton Biosciences, Inc.

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Arizona
      • Sun City, Arizona, Forente stater, 85023
        • Rekruttering
        • Healthcare Outcomes Performance Company
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Kearney
    • Georgia
      • Johns Creek, Georgia, Forente stater, 30097
        • Har ikke rekruttert ennå
        • Emory Orthopedics and Spine Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Casey Wagner
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Har ikke rekruttert ennå
        • Ochsner Health Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Maged Guirguis
    • Massachusetts
      • Burlington, Massachusetts, Forente stater, 01803
      • Chestnut Hill, Massachusetts, Forente stater, 02467
        • Har ikke rekruttert ennå
        • Mass General Brigham
        • Ta kontakt med:
        • Hovedetterforsker:
          • Robert Yong
    • New Jersey
      • Sewell, New Jersey, Forente stater, 08080
        • Har ikke rekruttert ennå
        • Virtua Health
        • Hovedetterforsker:
          • Sean McMillan
        • Ta kontakt med:
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74137
        • Rekruttering
        • The Orthopaedic Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yogesh Mittal
    • Pennsylvania
      • King of Prussia, Pennsylvania, Forente stater, 19406
        • Rekruttering
        • Rothman Orthopaedics
        • Ta kontakt med:
        • Hovedetterforsker:
          • Steve Stache
      • Sewickley, Pennsylvania, Forente stater, 15143
        • Rekruttering
        • Pain Diagnostics & Interventional Care
        • Hovedetterforsker:
          • David Provenzano
        • Ta kontakt med:
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • Har ikke rekruttert ennå
        • University of Texas Southwestern Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kelechi Okoroha
      • Houston, Texas, Forente stater, 77058
        • Rekruttering
        • All-American Orthopedic & Sports
        • Ta kontakt med:
        • Hovedetterforsker:
          • Matthew Higgs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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, amputation, or pseudoarthrosis.
  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, or shockwave therapy 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Triamcinolone acetate
Corticosteroid injection
Legemiddel: Triamcinolone acetate
A single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected.
Eksperimentell: ReneuRx
Enhet: ReneuRx
ReneuRx will be injected around the trochanteric branches of the femoral nerve.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Effectiveness
Tidsramme: 3-months post treatment
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
Tidsramme: Through study completion, an average of 12-months
Aggregate serious device-related adverse events through final follow-up visit
Through study completion, an average of 12-months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Effectiveness
Tidsramme: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
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
Tidsramme: 3 month and 6 month post-treatment
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
Tidsramme: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month
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
Tidsramme: 12 months post-treatment
Change in Timed-Up and Go (TUG) test scores
12 months post-treatment
Pain Relief
Tidsramme: 6-Month, 12-Month
Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.
6-Month, 12-Month

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exploratory Endpoint
Tidsramme: 12 months post-treatment

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
Tidsramme: 12 months post-treatment

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brixton Biosciences, Inc.

Samarbeidspartnere

MCRA

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. juli 2026

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

1. november 2029

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BTX-786-GTPS-02

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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