Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
NCT ID: NCT02944916
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2016-11-10
2017-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
IryPump R Set
Interventions
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IryPump R Set
Eligibility Criteria
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Inclusion Criteria
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
2. Patient already participating in another clinical study or who have previously participated in this investigation,
3. Pregnant or breast-feeding woman
18 Years
ALL
No
Sponsors
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BBraun Medical SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Charvier
Role: PRINCIPAL_INVESTIGATOR
Henry Gabrielle Hospital- St Genis Laval- France
Other Identifiers
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2016-A00631-50
Identifier Type: OTHER
Identifier Source: secondary_id
OPM-G-H-1601
Identifier Type: -
Identifier Source: org_study_id
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