Observational Study of Ostomy Consumers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational [Patient Registry]
SUMMARY

The purpose of this study is to gather data over a 5-year period directly from people living with an ostomy and their caregivers. Research participants will be asked to self-report on the ostomy pouching systems they typically use and other various aspects of living with an ostomy and/or caring for an individual living with an ostomy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Is at least 18 years of age; any self-reported gender

• Has a single Ileostomy, Colostomy, or Urostomy

• Is able to provide an informed consent for study participation with no cognitive impairment that would hinder the ability to provide informed consent or provide self-reported data

• Is willing and able to complete a once per month online questionnaire about life with an ostomy, or has a proxy who can enter data on their behalf

• Are able to respond themselves or appoint a caregiver as a proxy to respond to online computer questionnaires in English, French Canadian, or Spanish

Locations
United States
Illinois
Hollister Incorporated
Recruiting
Libertyville
Contact Information
Primary
Director Global Clinical Affairs
sara.wegener@hollister.com
224-206-2857
Time Frame
Start Date: October 4, 2018
Estimated Completion Date: February 2025
Participants
Target number of participants: 600
Treatments
Standard of Care
Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care
Authors
Renee Malandrino
Sponsors
Leads: Hollister Incorporated

This content was sourced from clinicaltrials.gov

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