BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

NCT04239183 | Unknown

• 1 other identifier: BE1
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Quality of Life of Colostomized Patient

Keywords

stomy; stomatherapy; colestomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Questionnaire

  1 month

• Biota Analysis

  1 month

Interventions

Stomatherapy DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• B. Braun Medical SA: lead

Central Study Contacts

MM

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 23, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01