Идёт набор NCT06664788

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

Без фазы С лечением Hemostasis Hemostatic Techniques

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ETHIZIA, SURGICEL Original.
Кому может быть актуально: Состояния в реестре: Hemostasis, Hemostatic Techniques. Базовые параметры: от 22 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery

Обзор

The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.

Вмешательства

Устройство ETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
Устройство SURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.

Первичные конечные точки

Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site [Срок оценки: Intraoperative (up to 10 minutes)]

Вторичные конечные точки (11)

Time to Hemostasis at Target Bleeding Site [Срок оценки: Intraoperative (up to 10 minutes)]
Percentage of Bleeding Sites Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at All Treated Bleeding Sites [Срок оценки: Intraoperative (up to 10 minutes)]
Time to Hemostasis for All Treated Bleeding Sites [Срок оценки: Intraoperative (up to 10 minutes)]
Median Time to Hemostasis at Target Bleeding Site [Срок оценки: Intraoperative]
Median Time to Hemostasis for All Treated Bleeding Sites [Срок оценки: Intraoperative]
Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites [Срок оценки: Intraoperative (up to 10 minutes)]
Sustained Hemostasis at All Treated Bleeding Sites [Срок оценки: Intraoperative]
Proportion of Bleeding Sites with Rebleeding After 10 Minutes [Срок оценки: Intraoperative]
Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original [Срок оценки: At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds]
Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis [Срок оценки: Intraoperative]
Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

Pre-operative

Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
Participant is willing and able to give written informed consent for the clinical investigation participation

Intra-operative

Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical
Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle
The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis
Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)

Критерии исключения

Pre-operative

Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
Participant has an active or suspected infection at the bleeding site
Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period

Intra-operative

Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine
Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет