NCT02602236终止不适用
Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
BBraun Medical SAS2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Description of efficacy in term of type of bag deployment and leakage prevention
研究概览
简要总结
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient is at least 18 years old
- •Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- •Patient having a colostomy for at least 1 month
- •Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
- •Patient having a stoma protusion smaller than or equal to 1.5 cm
- •Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
- •Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- •Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
- •Patient covered by social security
排除标准
- •Patient experiencing repeated leakages with the usual pouching system
- •Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- •Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
- •Patient already participating in another clinical study or who have previously participated in this investigation
- •Pregnant or breast-feeding woman
结局指标
主要结局
Description of efficacy in term of type of bag deployment and leakage prevention
时间窗: At least 1 time per day during 14±3 days
After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
次要结局
- Investigational product bag deployment reason(At each bag change during 14±3 days)
- Investigational device adhesivity during wear time(14±3 days)
- Overall security feeling questionnaire with the Investigational device(14±3 days)
- Overall satisfaction questionnaire with cap cover of the Investigational device(14±3 days)
- Ease of bag deployment(14±3 days)
- Ease of control of gas release button(14±3 days)
- Investigational device flexibility(14±3 days)
- General impression about body image during use of the investigational product(14±3 days)
- Assessment of the investigational device wear time(14±3 days)
- Assessment questionnaire preference between the investigational device and usual appliance(14±3 days)
- Investigational device discretion(14±3 days)
- Ease of base plate handling(14±3 days)
- Investigational device filter performance with undeployed bag(14±3 days)
- Overall satisfaction questionnaire with the Investigational device(14±3 days)
- Assessment questionnaire of willingness to use and the frequency of use in the future(14±3 days)
- Number of participants with Adverse Event as a measure of safety and tolerability(At baseline, at 5±3 days and 14±3 days)
- Overall satisfaction questionnaire regarding bag deployment of the Investigational device(14±3 days)
- Peristomal skin evaluation with DET score scale(baseline and 5±3 days and 14±3 days)
- Ease of special bag handling(14±3 days)
- Investigational device wearing comfort(14±3 days)
- Investigational device filter performance with deployed bag(14±3 days)
- Efficacy of Investigational device gas release button(14±3 days)
- Investigational product bag ease of use of gas release button(14±3 days)
- General impression about the investigational device before use(14±3 days)
- Noise during Investigational device wear time(14±3 days)
- Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device(14±3 days)
- Assessment of use of accessories(At each bag change during 14±3 days)
- Assessment of the quality of life with Stoma-QoL questionnaire(At baseline, at 5±3 days and 14±3 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With ColostomyColostomy StomaNCT03108105BBraun Medical SAS30
已完成
不适用
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With EnterostomyEnterostomyNCT02507726BBraun Medical SAS40
已完成
不适用
Treatment of Actinic Keratosis With 5% KOH SolutionActinic KeratosesNCT04024579Infectopharm Arzneimittel GmbH73
已完成
不适用
Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary CathetersUrinary CathetersRetention, UrinaryIncontinence, UrinaryAnesthesia, LocalNCT03289117Region Skane32
已完成
不适用
Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral LevelAmputationTraumatic AmputationLeg InjuryLower Limb InjuryNCT06284005Fondazione Don Carlo Gnocchi Onlus4