- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02944916
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
January 23, 2018 updated by: BBraun Medical SAS
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen Charvier, Henry Gabrielle Hospital- St Genis Laval- France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 10, 2016
Primary Completion (ACTUAL)
June 15, 2017
Study Completion (ACTUAL)
June 15, 2017
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (ESTIMATE)
October 26, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPM-G-H-1601
- 2016-A00631-50 (OTHER: FRENCH HEALTH AUTORITY)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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