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

Not Applicable

Completed

• Conditions: Therapeutic Irrigation
• Interventions: Device: IryPump R Set

• Registration Number: NCT02944916
• Lead Sponsor: BBraun Medical SAS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Study Start: 2016-11-10
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IryPump R Set	IryPump R Set	A new set for transanal irrigation composed by 2 parts : 1 pump and 1 rectal catheter . 1 rectal catheter used per irrigation respecting the patient usual frequency of transanal irrigation

Primary Outcome Measures

Name	Time	Method
Success of the trans anal irrigation (TAI) procedure	Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up	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).