이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

이 연구에서는 감각 신경 또는 혼합 운동 신경의 상지 신경 열상이 있는 환자에게 사용 시 수술용 신경 복구 제품인 NTX-001의 효과를 평가할 것입니다.

2026년 10월 2일 업데이트: Neuraptive Therapeutics Inc.

수술적 복구가 필요한 상지 절단 신경의 치료에서 표준 치료(신경경련)와 비교하여 NTX-001의 안전성과 효능을 평가하는 3상, 다기관, 무작위, 피험자 및 평가자 맹검, 대조 연구.

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

연구 유형

중재적

등록 (추정된)

98

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90048
        • 아직 모집하지 않음
        • Cedars Sinai Medical Center
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Meghan C McCullough, MD
      • San Francisco, California, 미국, 94158
        • 아직 모집하지 않음
        • UCSF Health
        • 연락하다:
        • 연락하다:
    • Florida
      • Orlando, Florida, 미국, 32806
      • Orlando, Florida, 미국, 32804
        • 모병
        • Rothman Orthopedics - Advent Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Amir Reza Kachooei, MD PhD
    • Georgia
      • Atlanta, Georgia, 미국, 30303
        • 모병
        • Grady Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Nicole A Zelenski, MD
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모병
        • University of Chicago
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Jeffrey Stepan, MD
    • Kentucky
      • Louisville, Kentucky, 미국, 40202
        • 모병
        • University of Louisville
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Tuna Ozyurekoglu, MD
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • 모병
        • Louisiana State University Health Sciences Center
        • 수석 연구원:
          • Harvey Chim, MD, FACS
        • 연락하다:
        • 연락하다:
          • Tanja Milosavljevic, MSc, PhD
          • 전화번호: 504-568-6876
          • 이메일: tmilos@lsuhsc.edu
    • Maryland
      • Baltimore, Maryland, 미국, 21218
        • 모병
        • Curtis National Center at MedStar Union Memorial Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Kenneth R Means Jr., MD
    • Missouri
      • Columbia, Missouri, 미국, 65211
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
        • 연락하다:
        • 수석 연구원:
          • David M Brogan, MD, MSc
        • 연락하다:
    • New Jersey
      • Camden, New Jersey, 미국, 08103
        • 모병
        • The Cooper Health System
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • David A Fuller, MD
    • New York
      • New York, New York, 미국, 10003
    • Ohio
      • Cincinnati, Ohio, 미국, 45267
        • 모병
        • UC Health
        • 수석 연구원:
          • Sonu Jain, MD
        • 연락하다:
        • 연락하다:
          • Brittany Rowley, CCRC Clinical Research Professional III
          • 전화번호: 513-558-2765
          • 이메일: rowleybm@ucmail.uc.edu
      • Cincinnati, Ohio, 미국, 45267
        • 모병
        • University of Cincinnati Health
        • 수석 연구원:
          • Sonu Jain, MD
        • 연락하다:
        • 연락하다:
      • Cleveland, Ohio, 미국, 44109
        • 모병
        • The MetroHealth System
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Kyle Chepla, MD
      • Columbus, Ohio, 미국, 43212
        • 모병
        • The Ohio State University Wexner Medical Center
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Ryan Schmucker, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모병
        • University of Pennsylvania, Department of Orthopaedic Surgery
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Ines C Lin, MD
      • Pittsburgh, Pennsylvania, 미국, 15212
        • 모병
        • Allegheny Health Network
        • 연락하다:
        • 연락하다:
          • Mary Fetter - Lead Clinical Research Coordinator
          • 전화번호: 412-359-8292
          • 이메일: Mary.Fetter@ahn.org
        • 수석 연구원:
          • Steven Regal, MD
    • South Carolina
      • Charleston, South Carolina, 미국, 29429
        • 모병
        • Medical University of South Carolina
        • 연락하다:
        • 연락하다:
          • Charles A Daly, MD
          • 전화번호: 843-876-2211
          • 이메일: dalyc@musc.edu
        • 수석 연구원:
          • Charles Daly, MD
    • Texas
      • Dallas, Texas, 미국, 75246
        • 모병
        • Baylor, Scott and White Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Asadullah Helal, MD
      • Lubbock, Texas, 미국, 79415
        • 모병
        • Texas Tech
        • 수석 연구원:
          • Brendan MacKay, MD
        • 연락하다:
        • 연락하다:
    • Utah
      • Salt Lake City, Utah, 미국, 84132
        • 모병
        • University of Utah Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Mark Mahan, MD, FAANS
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • 모병
        • UVA Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Brett DeGeorge, MD
    • Washington
      • Seattle, Washington, 미국, 98104
        • 모병
        • Harborview Medical Center
        • 연락하다:
        • 연락하다:
          • Yusha ( Katie) Liu, MD PhD
          • 전화번호: 206-744-3000
          • 이메일: HMCnerve@uw.edu
        • 수석 연구원:
          • Katie Liu, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
  • The subject is between eighteen (18) and eighty (80) years of age.
  • The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.

Exclusion Criteria:

  • Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
  • Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
  • Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
  • Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
  • The subject's injury is a result of a suicide attempt or self- harm.
  • The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
  • The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
  • The subject is pregnant or breastfeeding.
  • The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: NTX-001

NTX-001 used during the surgical repair of an upper extremity peripheral nerve injury in conjunction with standard suture neurorrhaphy.
조합 제품: NTX-001 (PEG-Fusion)

One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.
간섭 없음: Standard Suture Neurorrhaphy

Standard of Care

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)
기간: Screening Visit, Week 24

The subject will complete the MHQ questionnaire at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. A measure of the mean of MHQ in the Two Domains, Activities of Daily Living and Pain Scores, at Week 24 in the NTX-001 group as compared to Standard of Care (SoC). In the ADL subdomain, a higher component score indicates better function. In the Pain subdomain, a higher component score indicates greater pain. A total MHQ score of 100 is considered the best functional score.
Screening Visit, Week 24
Safety - Columbia-Suicide Severity Rating Scale
기간: Screening Visit, Weeks 4, 12, and 48

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a suicide risk assessment tool. The C-SSRS tool asks; whether and when the subject has had a thought about suicide (ideation); what actions they might have taken and what they did to prepare for suicide; whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition. The answers identify whether someone is at risk for suicide, assessing the severity and immediacy of that risk, and gauging the level of support that the person needs. The first assessment is done by study staff at screening. Subsequent assessments will be completed by the subject at Weeks 4, 12, and 48. A score of 0 indicates no risk, 1-2 indicates low risk, and 3+ indicates moderate to high risk.
Screening Visit, Weeks 4, 12, and 48

2차 결과 측정

결과 측정
측정값 설명
기간
Intraoperative CheckPoint® Stimulation.
기간: In Operating Room

A CheckPoint® Stimulator will be used intra-operatively to detect immediate reconnection of severed peripheral nerves (axons) in mixed-motor nerves only. The measures include in response of direct nerve stimulation, proximally and distally to suture site.
In Operating Room
MHQ Total Score
기간: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48

The MHQ quantifies different impairments between the subjects in uninjured and involved upper extremities. A general survey of hand function includes twenty-five items for the right and the left hand, as well as questions for both hands. Questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48
Time to Return to Function
기간: Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

Achievement of seventy-five (75)% function in the combined ADL and pain MHQ domain scores. The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Change in NPRS
기간: Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48

The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours.
Screening Visit, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 30, 36, 42, and 48
Semmes Weinstein Monofilament Test (SWMT)
기간: Weeks 2, 4, 8, 12, 24, 36, 48.

SWMT provides information on protective sensation, the rigorous system can detect relatively minor differences in sensory function, and changes will occur early in nerve injury. The assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments that subjects' can feel, range from 0.086 gm to 0.448gm. The normal value in the hand is in the range of the green filament (1.65 to 2.83 mN).
Weeks 2, 4, 8, 12, 24, 36, 48.
MHQ Two Domain Score
기간: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48

The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, 48
Change from Week 2 in MHQ Two Domain Score
기간: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

The Activities of Daily Living component evaluates the ability to perform specific tasks using either hand or both hands together. The Pain subdomain addresses the frequency and intensity of pain in both the right and left hands/wrists, along with its impact on sleep and daily activities, and the emotional distress it causes. The raw scale score for each of the 6 scales is the sum of the responses of each scale item. The raw score is converted to a score range from 0 to 100. 100 being the best.
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Medical Research Council Classification (MRCC) Sensory Score
기간: Weeks 2, 4, 8, 12, 24, 36, and 48.

The scale is commonly used including 2 Point Discrimination for grading the sensory outcome after peripheral nerve surgery. This scale is categorized into S0-S4: S0 is the absence of sensibility; S1 is the recovery of deep cutaneous pain; S2 is the return of superficial cutaneous pain and some degree of tactile sensibility; S3 is the return of superficial cutaneous pain and tactile sensibility without over response; and S4 is the complete recovery.
Weeks 2, 4, 8, 12, 24, 36, and 48.
Medical Research Council Classification (MRCC) Motor Score
기간: Weeks 2, 4, 8, 12, 24, 36, 48

This assessment is conducted on mixed motor nerve injuries only. Strength can best be assessed by isolating an individual muscle group and comparing power with that of the subject. It can be conducted to assess larger muscles or muscle groups as well as intrinsic muscles of the hand. Measuring the difference between the affected limb and the contralateral limb. 0/5 is no muscle activation whatsoever; 1/5 is muscle activation without limb movement; 2/5 implies that the limb can be moved only when gravity is taken out of the equation; 3/5 means that the subject can overcome gravity but not resistance;• 4/5 (or 4+ or 4-) implies weakness with enough strength to overcome varying degrees of physical resistance; 5/5 is full strength.
Weeks 2, 4, 8, 12, 24, 36, 48
Change from Baseline (W2) in Numeric Pain Rating Scale (NPRS)
기간: Weeks 2, 24.

The NPRS is used to assess for pain and to determine pain intensity. The NPRS is an 11-point scale scored from 0-10: 1) "0" = no pain 2) "10" = the most intense pain imaginable. The average of the 3 ratings is used to represent the subject's level of pain over the previous 24 hours.
Weeks 2, 24.
Patient Global Impression of Change Score
기간: Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48

This scale evaluates all aspects of patients; health and assesses if there has been an improvement or decline in clinical status. PGIC is a 7-point scale depicting a subjects rating of overall improvement. The subject rates their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Weeks 2, 4, 6, 8, 10, 12, 16, 20, 30, 36, 42, and 48
Change in Total MHQ Score
기간: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.

The MHQ quantifies different impairments between the subjects uninjured and involved upper extremities. It was designed as a general survey of hand function and includes twenty-five items for the right and the left hand, as well as questions for both hands. Furthermore, questions regarding function specifically refer to the impact of the involved hand and/or wrist on the activity which presumably takes all joints of the upper extremity into account. The overall questionnaire is scored from 0 to 100, with 100 being the optimal score.
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48.
Change from Baseline in Patient Global Impression of Severity Score (PGIS)
기간: Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.

The PGIS is a single question asking the subject to rate the severity of the injury from the last visit. PGIS is a scale depicting a subject's rating of overall severity. The subject scores their perception of severity as "none," "mild," "moderate," "severe," or "very severe."
Screening Visit; Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42 and 48.

기타 결과 측정

결과 측정
측정값 설명
기간
Electromyography (EMG) Testing
기간: Weeks 12, 24.

EMG will be used to detect reconnection of severed peripheral nerves (axons) using PEG Fusion. Restoration of nerve conduction indicates the restoration of axon continuity, which is a prerequisite for the prevention of Wallerian degeneration, neuromuscular junction degeneration, muscle atrophy and functional recovery. This testing will be done at select clinical sites.
Weeks 12, 24.
Nerve Conduction Velocity (NCV)
기간: Weeks 12, 24

NVC testing measures how fast an electrical impulse moves through a nerve. This testing will be done at select clinical sites.
Weeks 12, 24
Physical and Occupational Therapy
기간: Weeks 2, 4, 8, 12, 24, 36, and 48.

Each subject will have the number of times physical therapy and/or occupational therapy is prescribed to determine if this activity affects the sensory and functional outcomes of the nerve repair between NTX-001 and SOC.
Weeks 2, 4, 8, 12, 24, 36, and 48.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Neuraptive Therapeutics Inc.

수사관

  • 연구 책임자: Seth Schulman, MD, Neuraptive Therapeutics Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 10일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 4월 30일

연구 등록 날짜

최초 제출

2024년 9월 24일

QC 기준을 충족하는 최초 제출

2024년 9월 24일

처음 게시됨 (실제)

2024년 9월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NTx24301

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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