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

2026年4月28日 更新者: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.

研究概览

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Triamcinolone acetate
Corticosteroid injection
A single dose of Triamcinolone 40mg injected directly into the hip joint.
实验性的:ReneuRx
ReneuRx will be injected around the trochanteric branches of the femoral nerve.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Primary Effectiveness
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Secondary Effectiveness
大体时间: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
大体时间: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
大体时间: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
大体时间:12 months post-treatment
Change in Timed-Up and Go (TUG) test scores
12 months post-treatment
Pain Relief
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Exploratory Endpoint
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2029年11月1日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • BTX-786-GTPS-02

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

是的

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Triamcinolone acetate的临床试验

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