BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

B. Braun

Status: Unknown

Conditions: Quality of Life of Colostomized Patient

Treatments: Device: Stomatherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT04239183

BE1

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.