ICG Fluorescence in Knee Arthroscopy Study
Intraoperative Evaluation of Blood Flow for Knee Arthroscopy Using Indocyanine Green Fluorescence Angiography
The purpose of this study is to first evaluate whether ICG fluorescence angiography can be used to evaluate blood flow of the anterior cruciate ligament (ACL), tendons, and knee structures during an arthroscopic surgery. The secondary purpose is to evaluate differences in the blood flow in patients with varying grades of ACL tears.
To determine optimal intravenous dose of SPY Agent Green and time to visualize fluorescence in tendons and structures intraoperatively during arthroscopic surgery (if primary objective is deemed yes). We hypothesize that ICG will be effective in evaluating blood flow in patients undergoing knee arthroscopy.
調査の概要
状態
介入・治療
- 組み合わせ製品：Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)
- 組み合わせ製品：Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)
- 組み合わせ製品：Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose)
- 組み合わせ製品：Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose)
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Maxim A Jani, BS
- 電話番号：2488240579
- メール：mjani1@hfhs.org
研究場所
-
-
Michigan
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Detroit、Michigan、アメリカ、48202
- 募集
- Henry Ford Center for Athletic Medicine
-
コンタクト：
- Maxim A Jani, BS
- 電話番号：2488240579
- メール：mjani1@hfhs.org
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Patients undergoing knee arthroscopy with a HFH Orthopaedic surgeon
- Patients must be within ages of 14-89. Patient ages 14-17 will be included to capture an important sporting demographic who sustain ACL injuries which would stand to benefit from this intervention if successful.
- Have signed an approved informed consent form for the study.
- Be willing to comply with the protocol
Exclusion Criteria:
Patient is less than 14 years of age or greater than 89 years of age
- Patients who have had iodide-based radiology studies within the last seven (7) days prior to surgery
- Previous surgical repair of targeted surgical area
- Known allergy or history of adverse reaction to SPY Agent Green, ICG,
- Subjects who have participated in another investigational study within 30 days prior to surgery.
- Pregnant or lactating subjects.
- Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigational procedure, or interfere with the interpretation of study results.
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：診断
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- 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 |
|---|---|
|
実験的：2 mL of SPY Agent Green (5.0 mg dose)
Cohort #1: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 2 mL of SPY Agent Green (5.0 mg dose) |
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose).
Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues.
Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
|
|
実験的：3 mL of SPY Agent Green (7.5 mg dose)
Cohort #2: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 3 mL of SPY Agent Green (7.5 mg dose) |
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose).
Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues.
Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
|
|
実験的：4.0 mL of SPY Agent Green (10.0 mg dose)
Cohort #3: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 4.0 mL of SPY Agent Green (10.0 mg dose) |
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose).
Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues.
Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
|
|
実験的：5.0 mL of SPY Agent Green (12.5 mg dose)
Cohort #4: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 5.0 mL of SPY Agent Green (12.5 mg dose) |
Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 5 mL of SPY Agent Green (12.5 mg dose).
Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues.
Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
|
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 |
|---|---|---|
|
Fluorescence signal
時間枠：From enrollment to first follow up appointment.
|
To determine if a fluorescence signal is present in knee structures during arthroscopic surgery after an intravenous administration of SPY Agent Green is given.
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From enrollment to first follow up appointment.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Vasilios Moutzouros, MD、Henry Ford Health System
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- 17358-09
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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