NCT02944916CompletedNot Applicable
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
BBraun Medical SAS0 sites15 target enrollmentStarted: November 10, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Primary Endpoint
- Success of the trans anal irrigation (TAI) procedure
Study Overview
Brief Summary
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is at least 18 years old,
- •Patient having signed an informed consent
- •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.
- •Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently
- •Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver
- •Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- •Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.
- •Patient covered by social security
Exclusion Criteria
- •Patient with bowel obstruction
- •Patient already participating in another clinical study or who have previously participated in this investigation,
- •Pregnant or breast-feeding woman
Outcomes
Primary Outcomes
Success of the trans anal irrigation (TAI) procedure
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
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