Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

Therapeutic Irrigation Clinical Trial

Official title:

Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944916
• Other study ID #: OPM-G-H-1601
• Secondary ID: 2016-A00631-50
• Status: Completed
• Phase: N/A
• First received: September 20, 2016
• Last updated: January 23, 2018
• Start date: November 10, 2016
• Est. completion date: June 15, 2017

Study information

• Verified date: January 2018
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is at least 18 years old,

2. Patient having signed an informed consent

3. Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results.

4. Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently

5. Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver

6. Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)

7. Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.

8. Patient covered by social security

Exclusion Criteria:

1. Patient with bowel obstruction

2. Patient already participating in another clinical study or who have previously participated in this investigation,

3. Pregnant or breast-feeding woman

Related Conditions & MeSH terms

• Intestinal Diseases
• Therapeutic Irrigation

Intervention

Device:
• IryPump R Set

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of the trans anal irrigation (TAI) procedure	The patient will practice TAI following his usual frequency (depending on his intestinal transit). After each TAI, the patient will evaluate the success of the procedure (defined as satisfying output evacuation of the bowel according to the patient usual pattern in term of volume of water instilled and absence of leakages between 2 irrigations).	Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up