Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

28. April 2026 aktualisiert von: 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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Triamcinolone acetate
Corticosteroid injection
A single dose of Triamcinolone 40mg injected directly into the hip joint.
Experimental: ReneuRx
ReneuRx will be injected around the trochanteric branches of the femoral nerve.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Primary Effectiveness
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Secondary Effectiveness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months post-treatment
Change in Timed-Up and Go (TUG) test scores
12 months post-treatment
Pain Relief
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Exploratory Endpoint
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

1. November 2029

Studienanmeldedaten

Zuerst eingereicht

21. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. April 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • BTX-786-GTPS-02

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Greater Trochanteric Pain Syndrome

Klinische Studien zur Triamcinolone acetate

Abonnieren