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临床试验/NCT02517541
NCT02517541已完成不适用

A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Coloplast A/S17 个研究点 分布在 4 个国家目标入组 74 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Coloplast A/S
入组人数
74
试验地点
17
主要终点
Leakage Under the Baseplate (cm^2)

研究概览

简要总结

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

详细描述

72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.

Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.

The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.

The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Have an ileostomy or colostomy
  • Have had their ostomy for at least 3 months
  • Must use 1 piece open or closed ostomy products during the test period
  • Currently using a 1 piece. flat product
  • Must be able to use custom cut product
  • Have intact peristomal skin
  • Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
  • Are evaluated to be suitable for a soft convex product

排除标准

  • Currently receiving or have within the past 2 month received radio- and/or chemotherapy
  • Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
  • Are pregnant or breastfeeding
  • Participating in other interventional clinical investigations or have previously participated in this investigation

结局指标

主要结局

Leakage Under the Baseplate (cm^2)

时间窗: 14 weeks (2 weeks baseline + 12 weeks intervention)

The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.

次要结局

未报告次要终点

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (17)

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