BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES (BE1)

A comparative study on the improvement of quality of life of colostomized patients using the new Be1 device with capsule system.

Study Overview

• Status: Unknown
• Conditions: Quality of Life of Colostomized Patient
• Intervention / Treatment: Device: Stomatherapy

Detailed Description

The primary objective is to demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire) among descending colostomy patients, establishing the following comparisons:

1. Patients with recent surgery who after one month using a current two-piece mechanical device switch to the new Be1 device with capsule system versus patients who after one month continue to use the same current two-piece mechanical device during four months.
2. Patients who have been using a current two-piece mechanical device during more than 6 months after an ostomy and agree to switch to the new Be1 device with capsule system during four months.

The following secondary objectives have been defined:

• Assessment of patient satisfaction with the new Be1 device with capsule system versus a current two-piece mechanical device.
• Demonstration that the new Be1 device with capsule system improves the microbiota of the colostomized patient.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: MM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will involve descending colostomy patients. There are three study groups. Two of them will comprise new patients (recently subjected to surgery), while the third will consist of patients with an ostomy for at least 6 months (pre-existing patients).

The sample size will comprise 240 patients (85 patients in the mentioned two groups and 70 in the third).

Description

Inclusion Criteria:

- Inclusion criteria groups 1 and 2

• Patients of at least 18 years of age.
• Recently operated patients with a descending colostomy.
• Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
• Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements.
• Patients who in the opinion of the stoma therapist are candidates for a two-piece mechanical device.

Inclusion criteria group 3

• Patients of at least 18 years of age.
• Patients with a descending colostomy for over 6 months and who carry a two-piece mechanical device.
• Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
• Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements
• Patients who in the opinion of the stoma therapist are candidates for use of the Be1 device with capsule system.

Exclusion Criteria:

Exclusion criteria groups 1 and 2

• Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
• Patients who are participating in another study.
• Patients with multiple stomas.
• Vulnerable patients or subjects under legal tutelage.
• Patients with known allergy to any of the components of the study product.
• Patients with a retracted stoma.
• Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.

Exclusion criteria group 3

• Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
• Patients who are participating in another study.
• Patients with multiple stomas.
• Vulnerable patients or subjects under legal tutelage.
• Patients with known allergy to any of the components of the study product.
• Patients with a retracted stoma.
• Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
StomaQoL	to demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire) among descending colostomy patients	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Assessment of patient satisfaction with the new Be1 device with capsule system versus a current two-piece mechanical device.	1 month
Biota Analysis	Demonstration that the new Be1 device with capsule system improves the microbiota of the colostomized patient	1 month

Collaborators and Investigators

• Sponsor: B. Braun Medical SA

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: stomy; stomatherapy; colestomy
• Other Study ID Numbers: BE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No