BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

Quality of Life of Colostomized Patient Clinical Trial

— BE1  

Official title:

BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04239183
• Other study ID #: BE1
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: B. Braun Medical SA
• Contact: MM
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life of Colostomized Patient

Intervention

Device:
• Stomatherapy
Demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire (21)) among descending colostomy patients, establishing the following comparisons.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical SA

Outcome

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