がん関連悪性腹水を有する女性のための在宅穿刺(腹水穿刺) (Paracentesis)
がん関連悪性腹水を有する女性のための在宅穿刺術のパイロット研究:分散型介入治療試験(穿刺術)
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Susan Sharry
- 電話番号:801-585-3453
- メール:susan.sharry@hci.utah.edu
研究場所
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- 募集
- Huntsman Cancer Institute at the University of Utah
-
コンタクト:
- Susan Sharry
- 電話番号:801-585-3453
- メール:Susan.sharry@hci.utah.edu
-
-
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:
- Participants aged ≥ 18 years
- Able to speak and understand English.
- Has completed an initial clinic-based paracentesis procedure.
- Confirmed diagnosis of cancer.
- Symptoms related to ascites requiring procedure in the opinion of the investigator.
- Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator.
- If applicable, participant is able to safely hold anticoagulant therapy per institutional standards prior to the procedure in the opinion of the investigator.
- For participants of child-bearing potential, participant is following standard of care guidelines for contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- Rapidly deteriorating condition or suspected bowel obstruction.
- Large ventral hernias or prior complications from paracentesis.
- Need for concurrent procedures requiring hospital resources.
- Known lack of safe environment or inability to obtain sterile conditions at home.
- Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example,
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
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:なし
- 介入モデル:単一グループの割り当て
- 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:At-home Paracentesis
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
Paracentesis is a bedside procedure to obtain ascitic fluid from the peritoneum through needle aspiration, performed for both diagnostic and therapeutic purposes. The procedure involves needle insertion into the peritoneal cavity to remove fluid for analysis or to relieve symptoms from tense ascites. |
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 |
|---|---|---|
|
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
時間枠:3 months
|
To evaluate the change in symptoms in patients who complete at-home paracentesis. The AIM survey consists of 3 questions from 0 (No Symptoms) to 5 (Very Severe). A lower score is better. At the end of the study, all the results will be added together for the TSS. A lower score is preferred to show a positive outcome. |
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
時間枠:3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
時間枠:3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
時間枠:3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
時間枠:3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.
時間枠:3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.
時間枠:3 months
|
To assess the rate of procedure-related complications after at-home paracentesis. |
3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Anna Beck, MD、Huntsman Cancer Institute
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
- HCI198711
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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