Health Condition 1: K638- Other specified diseases of intestine
Conditions
Interventions
Intervention1: Sphinx Medical Device: the investigator will evaluate the subject and the viability of stoma. Ultrasound will be used to evaluate the abdominal wall thickness. The first 2 days will be
Sponsors
Ms Crimson Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject has had end colostomy/ileostomy for at least 1 month. 2. Subject has intact skin with no sign of major deterioration or wound/fistula around the stoma.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Suffering from peristomal skin problems, dermatitis, bleeding, fistula etc.. 3. Inflammatory stoma/intestine. 4. Tendency of frequent stomal bleeding, liquid stool or constipation. 5. Peristomal hernia. 6. Stoma protrusion greater than 2cm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complications and the ability of fecal matter to pass through the device.Timepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes will be effectiveness, and will include: 1. Sealing 2. Anchoring of the device in place during routing use (Bending over, flatus, bowel evacuation etc.) 3. Device structural integrity 4. Ability to release flatus without leakage of liquid or solid matterTimepoint: 2 weeks | — |
Countries
India
Contacts
Public ContactDr Alben Sigamani
Mazumdar Shaw Medical Center
Outcome results
None listed