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
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Luca Remonda, Prof.
- 電話番号:+41 62 838 43 21
- メール:luca.remonda@ksa.ch
研究場所
-
-
Aargau
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Aarau、Aargau、スイス、5001
- 募集
- Department of Neuroradiology, Kantonsspital Aarau
-
コンタクト:
- Luca Remonda, Prof.
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の: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.
|
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Puncture accuracy
時間枠:during procedure time approximately 30 min.
|
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
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during procedure time approximately 30 min.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of control acquisitions to achieve target
時間枠:during procedure time approximately 30 min.
|
Number of control acquisitions to achieve target
|
during procedure time approximately 30 min.
|
|
Assessment of radiation dose
時間枠:during procedure time approximately 30 min.
|
Assessment of radiation dose
|
during procedure time approximately 30 min.
|
|
Assessment of intervention time
時間枠:during procedure time approximately 30 min.
|
Assessment of intervention time
|
during procedure time approximately 30 min.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Luca Remonda, Prof.、Department of Neuroradiology, Kantonsspital Aarau
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。