Back to resultsPilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
Primary Purpose
Therapeutic Irrigation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IryPump R Set
Sponsored by
About this trial
This is an interventional supportive care trial for Therapeutic Irrigation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IryPump R Set
Arm 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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02944916
First Posted
September 20, 2016
Last Updated
January 23, 2018
Sponsor
BBraun Medical SAS
1. Study Identification
Unique Protocol Identification Number
NCT02944916
Brief Title
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
Official Title
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BBraun Medical SAS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Irrigation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IryPump R Set
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
IryPump R Set
Primary Outcome Measure Information:
Title
Success of the trans anal irrigation (TAI) procedure
Description
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).
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Charvier
Organizational Affiliation
Henry Gabrielle Hospital- St Genis Laval- France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
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