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Safety and Performance of New 1-piece Ostomy Product

2017年3月17日 更新者:Coloplast A/S

Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

研究概览

详细说明

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Humlebæk、丹麦、3050
        • Holtedam 3

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Have given written informed consent and signed letter of authority form.
  2. Be at least 18 years of age and have full legal capacity.
  3. Be able to handle the bags themselves.
  4. Have an ileostomy with a diameter between 15 and 40 mm.
  5. Have had their ostomy for at least three months.
  6. Currently use a 1-piece flat ostomy appliance with open bag.
  7. Use minimum 1 ostomy appliance every second day.
  8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
  9. Must be able to use a custom cut ostomy appliance.
  10. Accept to test three 1-piece ostomy appliances in the investigation.
  11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion Criteria:

  1. Use irrigation during the study (flush the stoma with water).
  2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
  3. Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
  4. Are pregnant or breastfeeding.
  5. Participating in other interventional clinical investigations or have previously participated in this investigation.
  6. Currently using ostomy belt.
  7. Currently using extended wear product.
  8. Known hypersensitivity towards any of the test products
  9. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Treatment sequence 1

The subjects randomised to Treatment sequence 1 are going to test

  1. Coloplast Adhesive baseplate A (A)
  2. Coloplast Adhesive baseplate B (B)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: ABS; BSA; SAB

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
实验性的:Treatment sequence 2

The subjects randomised to Treatment sequence 2 are going to test

  1. Coloplast Adhesive baseplate B (B)
  2. Coloplast Adhesive baseplate C (C)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: CBS; BSC; SCB

Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
实验性的:Treatment sequence 3

The subjects randomised to Treatment sequence 3 are going to test

  1. Coloplast Adhesive baseplate A (A)
  2. Coloplast Adhesive baseplate B (C)
  3. SenSura 1-piece (S)

The subjects test the three test products in a randomised order: ACS; CSA; SAC

Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Degree of Leakage
大体时间:one week

The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.

The subjects had to tick off one of the following choices:

  1. No leakage
  2. Starting to leak
  3. Leakage
  4. Sudden Leakage
one week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Birte Jakobsen, Dr.、Coloplast A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年2月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2013年2月22日

首先提交符合 QC 标准的

2013年2月27日

首次发布 (估计)

2013年2月28日

研究记录更新

最后更新发布 (实际的)

2017年4月14日

上次提交的符合 QC 标准的更新

2017年3月17日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • CP236

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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