NCT01800890已完成不适用
Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
详细描述
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Have given written informed consent and signed letter of authority form.
- •Be at least 18 years of age and have full legal capacity.
- •Be able to handle the appliances themselves
- •Have an ileostomy with a diameter between 15 and 40 mm.
- •Have had their ostomy for at least three months.
- •Use minimum 1 baseplate every third day.
- •Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
- •Must be able to use custom cut product
- •Accept to test three 2-piece products within the study.
- •Negative result of a pregnancy test for women of childbearing age.
排除标准
- •Use irrigation during the study (flush the stoma with water).
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- •Are pregnant or breastfeeding.
- •Participating in other interventional clinical investigations or have previously participated in this investigation.
- •More than three days wear time as usual change pattern.
- •Currently using ostomy belt
- •Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
- •Have a loop ileostomy
- •Known hypersensitivity towards any of the test products
- •Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
结局指标
主要结局
Degree of Leakage
时间窗: 10 days
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Study of the Safety and Effectiveness of NXN-188 for the Acute Treatment of Migraine Attacks With AuraMigraine With AuraNCT00877838Danish Headache Center40
已完成
不适用
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-pieceIleostomy - StomaNCT01957553Coloplast A/S130
已完成
2 期
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAHEndocrine DiseaseAdrenal InsufficiencyCongenital Adrenal HyperplasiaNCT01735617Diurnal Limited16
Unknown
4 期
Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal PositionAneurysmal Disease of the Abdominal AortaOcclusive Disease of the Abdominal AortaNCT00824109Datascope Corp.60
终止
2 期
A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular PathologyAlzheimer's Disease With Vascular PathologyNCT04798989Tisento Therapeutics12