Clinical trial NCT03549780: Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
Official title: A Pilot Study of a Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: Brooke Ileostomy
stoma
ileostomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 2 hours
Secondary outcomes:
measure: Function (continence of device); observed leakage
timeFrame: 2 hours
Other outcomes:
measure: Questionnaire
timeFrame: 2 hours
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William A Faubion, M.D.
role: PRINCIPAL_INVESTIGATOR
References: