BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES | NCT04239183

Studies
BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES

NCT04239183

Sponsor

B. Braun Medical SA

Status

Unknown status

Last Update Posted

Jan 23, 2020Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Quality of Life of Colostomized Patient

Interventions

Stomatherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Jan 16, 2020

First Submission Date that Met QC Criteria

Jan 22, 2020

First Posted Date

Jan 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2020

Last Update Posted Date

Jan 23, 2020Actual

Description Module

Brief Summary

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

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:

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.
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.

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample