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

B. Braun

Status: Completed

Conditions: Therapeutic Irrigation

Treatments: Device: IryPump R Set

Study type: Interventional

Funder types: Industry

Identifiers

NCT02944916

2016-A00631-50 (Other Identifier)

OPM-G-H-1601

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

IryPump R Set

Experimental group

Description:

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

Treatment:

Device: IryPump R Set