Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method (PunctureCube)
Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
연구 개요
상세 설명
Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture Cube® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Luca Remonda, Prof.
- 전화번호: +41 62 838 43 21
- 이메일: luca.remonda@ksa.ch
연구 장소
-
-
Aargau
-
Aarau, Aargau, 스위스, 5001
- 모병
- Department of Neuroradiology, Kantonsspital Aarau
-
연락하다:
- Luca Remonda, Prof.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients requiring a percutaneous therapeutic CT-guided intervention for
- lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level)
- age ≥ 18 years
- Signed informed consent prior to intervention
Exclusion Criteria:
- Patients suffering from severe obesity (BMI > 30 kg/m2)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Free-hand lumbar punction
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
|
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
|
|
활성 비교기: Puncture Cube
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
|
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Puncture accuracy
기간: during procedure time approximately 30 min.
|
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
|
during procedure time approximately 30 min.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of control acquisitions to achieve target
기간: during procedure time approximately 30 min.
|
Number of control acquisitions to achieve target
|
during procedure time approximately 30 min.
|
|
Assessment of radiation dose
기간: during procedure time approximately 30 min.
|
Assessment of radiation dose
|
during procedure time approximately 30 min.
|
|
Assessment of intervention time
기간: during procedure time approximately 30 min.
|
Assessment of intervention time
|
during procedure time approximately 30 min.
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Luca Remonda, Prof., Department of Neuroradiology, Kantonsspital Aarau
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
요통에 대한 임상 시험
-
BioAlpha Inc.알려지지 않은Transforaminal Lumbar Interbody Fusion
-
Kyungpook National University Hospital알려지지 않은
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Tanta Universitymona bologh elmorad,MD; mohmed naser shaddad,MD완전한이중 레벨 요추 척추전방전위증(L3-L5) | PLIF(Posterior Lumbar Interbody Fusion) | 요추 고정 수술이집트
-
Taipei Veterans General Hospital, Taiwan완전한퇴행성 요추 척추 협착증 | 요추 보조기 | Transforaminal Lumbar Interbody Fusion대만
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)