NCT06547905已完成不适用
Evaluation of an Ostomy Leakage Detection System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The Accuracy of the Leakage Detection System (LDS)
研究概览
简要总结
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
详细描述
Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years or Older
- •Currently resides in the United Kingdom
- •Has an ileostomy, colostomy, or urostomy
- •Has a stoma diameter within the following range: 15 mm - 70 mm
- •Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).
- •Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days
- •Willing to use their typical ostomy pouching system together with the study product for duration of study
- •Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS):
- •a. Android Devices:
- •i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel
- •ii. Operating System: Android OS 9.0 (Pie) and later
- •b. Apple iPhones:
- •i. Compatible Models: iPhone X and later
- •ii. Operating System: iPhone Operating System (iOS) 15 and newer
- •Is willing to download the phone application for use during the study
- •Is willing to follow protocol procedures, as indicated by signing the informed consent
- •Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)
排除标准
- •Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
- •Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
- •Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
- •Reports as legally blind and/or deaf
- •Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
- •Subject reports currently having an abdominal fistula or abdominal wound
- •Subject has more than one stoma
- •Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
- •Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility.
- •Is currently involved in another research study involving use of ostomy study products or accessories
- •Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories
结局指标
主要结局
The Accuracy of the Leakage Detection System (LDS)
时间窗: through study completion, approximately 1 month
The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.
次要结局
- How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)(through study completion, approximately 1 month)
- Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool(through study completion, approximately 1 month)
- How adherent subjects are to leakage notifications (ratio)(through study completion, approximately 1 month)
- Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool(through study completion, approximately 1 month)
- Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool(through study completion, approximately 1 month)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Performance Study of Newly Developed Ostomy ProductsStoma ColostomyNCT01513330Coloplast A/S122
已完成
不适用
Assessment of the Performance of a New Ostomy Device in Subjects Having an IleostomyIleostomy - StomaNCT03439241Coloplast A/S20
招募中
2 期
Efficacy evaluation of Overflow leak test by 30 mL intrathecal injectioJPRN-jRCTs061220082akai Eiichi25
Unknown
不适用
The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer SurgeryAnastomotic LeakageNCT05191602Southwest Hospital, China300
已完成
2 期
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and ComfortColostomyNCT01243294Coloplast A/S56