Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | March 2019 |
| End Date: | July 2019 |
| Contact: | Jessica Friton |
| Email: | friton.jessica@mayo.edu |
| Phone: | 507-284-0495 |
A Pilot Study of a Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
This investigation constitutes an initial evaluation of the stoma occlusion device in humans
with a mature permanent Brooke ileostomy. The overall objective of this study is to assess
feasibility and initial operating characteristics of a novel stoma occlusion device. The
study will recruit 20 patients for placement of the device into the mature Brooke ileostomy
and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2
hours.
with a mature permanent Brooke ileostomy. The overall objective of this study is to assess
feasibility and initial operating characteristics of a novel stoma occlusion device. The
study will recruit 20 patients for placement of the device into the mature Brooke ileostomy
and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2
hours.
An ostomy is a protrusion of part of the intestines extending through the abdominal wall for
the purpose of elimination of wastes and may be temporary or permanent depending on the
purpose of the initial surgery. The most common reasons for permanent bowel diversion are
cancer and ulcerative colitis. Appliances have improved greatly over the last 50 years, but
patients continue to experience appliance leakage and skin infections and struggle with the
emotional and social impact of an external pouch. This study seeks to answer the opportunity
to significantly improve quality of life to a large segment of the global population through
optimization of a technology for a stoma occlusion device in patients with permanent stomas.
Four pre-clinical animal studies have been conducted. All the animals that completed the
study tolerated the device well and had no adverse reactions to device materials. This
project will allow a prototype of an artificial stomal occlusion device to be tested in
humans.
the purpose of elimination of wastes and may be temporary or permanent depending on the
purpose of the initial surgery. The most common reasons for permanent bowel diversion are
cancer and ulcerative colitis. Appliances have improved greatly over the last 50 years, but
patients continue to experience appliance leakage and skin infections and struggle with the
emotional and social impact of an external pouch. This study seeks to answer the opportunity
to significantly improve quality of life to a large segment of the global population through
optimization of a technology for a stoma occlusion device in patients with permanent stomas.
Four pre-clinical animal studies have been conducted. All the animals that completed the
study tolerated the device well and had no adverse reactions to device materials. This
project will allow a prototype of an artificial stomal occlusion device to be tested in
humans.
Inclusion Criteria:
- Age range: 18 and older
- Gender: Male and Female
- Target disease or condition: 20 patients with permanent End Ileostomy, specifically
Brooke ileostomy for greater than 3 years
- Ability to comply with protocol
- Competent and able to provide written informed consent
Exclusion Criteria:
- Inability to provide consent
- Crohn's Disease
- Koch pouch
- Pregnancy
- If subject's stoma length is less than 4 cm or longer than 8 cm
- Clinically significant medical conditions within the six months before participation
with the device that would, in the opinion of the investigators, compromise the safety
of the patient.
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