NL-OMON55236已完成不适用
Prospective, multicenter study to evaluate the Safety and performance of a syntHetic tissue sealant in reducing fluid lEakage following elective hepatobiLiary anD pancreatic Surgery - SHIELDS
Polyganics BV, Groningen0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Preoperative
- •- Subjects who are able to provide a written informed consent prior to
- •participating in the clinical investigation
- •- Subjects who are >= 18 years old.
- •- Subjects who are able to comply with the follow-up or other study requirements
- •- Subjects who are planned for an elective hepatic resection surgery or
- •elective distal pancreatectomy surgery
- •Intraoperative
- •- Patch is applied manually (during open procedure, conversion procedure, or
- •laparoscopic assisted procedure)
排除标准
- •Preoperative
- •- Female subjects who are pregnant and/or breastfeeding
- •- Subjects with a known allergy to any of the components of the Sealing Device
- •(Polyurethane sheet with DC-Green #6 dye and Polyurethane matrix foam with
- •8-Arm-PEG40k succinimidyl carbonate adhesive and Disodium Hydrogen Phosphate)
- •- Subjects with bleeding disorders requiring anti-coagulation medication
- •(except acetylsalicylic acid)
- •- Subjects who receive double-anti coagulation
- •- Subjects who receive peritoneal dialysis
- •- Subjects with a presence of systemic infection
- •- Subjects who previously participated in this study, or in any investigational
- •drug- or device study within 30 days of screening
- •- Subjects who previously required liver transplantation
- •- Subjects undergoing a procedure requiring an anastomosis (e.g. Klatskin
- •tumours or Whipple)
- •Additional for liver group
- •- Subjects with liver cirrhosis Grade C on the Child-Turcotte-Pugh score
- •Intraoperative
- •- Subjects with multivisceral resections, except resection of spleen
- •NOTE: multivisceral resections are defined when, in addition to resection of
- •liver or pancreas, any of the following organs are resected:
- •- Intestine/bowel
- •- Liver (if resection is more than a biopsy), when patient is to be included in
- •the pancreas group
- •- Pancreas (if resection is more than a biopsy), when patient is to be included
- •in the liver group
- •- Not able to apply the patch(es) according to the instructions for use
- •- Total surgery requiring > 3 HPB Sealing Devices of 10 x 5 cm (which equals a
- •resection surface of more than 88 cm2)
- •Additional for liver group
- •- Subjects with a Grade 3 or 4 bleeding after liver transection (Lewis 2016)
- •- Subjects with liver cirrhosis Grade C on the Child-Turcotte-Pugh score
- •Additional for pancreas group
- •- A margin of <1 cm between the defect and the portal vein
- •NOTE: The margin is intended to ensure sufficient normal tissue is left of the
- •pancreatic stump to be able to have a 1 cm overlap of the device on the tissue
- •of the pancreas. There is no contra-indication of the device with regards to
- •placement on veins, as indicated in the Instructions For Use where no
- •contra-indications for the device have been identified. Therefore, as long as
- •there is 1 cm tissue on the pancreatic stump left for overlap of the device,
- •the patient can be included into the study based upon this criterium.
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