Health Condition 1: K508- Crohns disease of both small andlarge intestine
Conditions
Interventions
Intervention1: Evaluation of new Continent Ostomy Management System SphinX, for management of stable adult intestinal ostomies: The study will continue until 10 patients are included. The patients wil
Sponsors
CRIMSON HEALTHCARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject is 18 years and older. 2.Subject has had end colostomy or end ileostomy for at least 1 month. 3.Subject has mental capacity to understand guidelines and feedback questionnaire. 4.Subject has no fistula around the stoma. • Subject has been evaluated by the investigator to have a stoma and other conditions suitable for this study. • Subject has successfully completed the preliminary evaluation stage conducted by the investigator. (Described later in the document) • Subject signs and date the written informed consent form and indicates the understanding of the study procedures
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women. Suffering from fistula as examined by the investigator. Receiving or have received within the past 2 months any therapies such as chemotherapy/radiation etc. Subject has abdominal wall thickness greater than 40mm. Participating in any other clinical study. Inflammatory stoma/intestine. Tendency of frequent stomal bleeding, diarrhea or constipation. Peristomal hernia. Stoma protrusion greater than 2 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety – evaluated by monitoring adverse events (AE) and condition of peristomal skin using validated Ostomy Skin Tool (DET scoring) after 6 hours of use.Timepoint: Safety – evaluated by monitoring adverse events (AE) and condition of peristomal skin using validated Ostomy Skin Tool (DET scoring) after 6 hours of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Stool evacuation, stool leakage, device anchoring after 6 hours of use. QoL and satisfaction Evaluation: Subject comfort with the device, ease of use, QoL (Quality of Life) evaluation using validated Stoma QoL questionnaire. Safety and Efficacy after 48 hours of use. Timepoint: 48 hours | — |
Countries
India
Contacts
Public ContactProfessor Vineet Ahuja
All India Institute of Medical Sciences
Outcome results
None listed