Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nuevo León
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Monterrey、Nuevo León、メキシコ、64460
- Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
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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:
- Provision of signed and dated Informed Consent Form
- Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
- Female, age 18 years or older
- Indicated for Total Laparoscopic Hysterectomy
Exclusion Criteria:
- HIV
- Hepatitis C
- Diabetics
- Use of systemic corticosteroids
- History of pelvic irradiation
- Active infection
- History of bleeding problems/hemophilia
- Cancer
- Cases in which vaginal cuff closure is intended to be performed robotically
- Pregnant
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:デバイスの実現可能性
- 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 |
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実験的:Single Study Site: UANL
As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy.
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The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.
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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 |
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Device Ease of Use
時間枠:Immediately following procedure
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Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy.
Assessed following surgery by standardized surgeon interview.
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Immediately following procedure
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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 |
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Vaginal Cuff Closure
時間枠:During procedure.
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Assessment of quality of vaginal cuff closure following uterine excision.
Performed by surgeon as operative standard of care.
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During procedure.
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Vaginal Cuff Closure Time
時間枠:During Procedure.
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Procedural time from uterine excision to successful vaginal cuff closure.
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During Procedure.
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Total Surgical Time
時間枠:During Procedure.
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Total procedural time.
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During Procedure.
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Device Use Learning Curve assessed with a Surgeon Survey
時間枠:Assessed immediately following study completion during surgeon survey.
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Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
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Assessed immediately following study completion during surgeon survey.
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Sexual Discomfort
時間枠:Assessed at 1 and 6 week follow-up visits.
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Measurement of subject discomfort during sexual activity following completion of surgical procedure.
Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).
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Assessed at 1 and 6 week follow-up visits.
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Dan Mazzucco, PhD、ZSX Medical LLC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- ZHP01-1.0
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
米国で製造され、米国から輸出された製品。
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。
腹腔鏡下子宮全摘出術の臨床試験
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University of Zurich完了