Therapeutic IrrigationNCT02944916
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
A study testing IryPump R Set in people with Therapeutic Irrigation, run by BBraun Medical SAS.
Trial summary
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Irrigation
- What is being tested?
- IryPump R Set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2016to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with bowel obstruction
- Patient already participating in another clinical study or who have previously participated in this investigation,
- Pregnant or breast-feeding woman
About this study
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
- Conditions
- Therapeutic Irrigation
- Being tested
- IryPump R Set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IryPump R SetDevice
| Study group | Role | What they receive |
|---|---|---|
| IryPump R Set | Experimental | 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 Receives: Device: IryPump R Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start10 Nov 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic IrrigationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Charvier, Principal investigator, Henry Gabrielle Hospital- St Genis Laval- France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944916
- Sponsor's protocol ID
- OPM-G-H-1601
- Other IDs
- 2016-A00631-50
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders
- ClinicalTrials.gov ID
- NCT02944916
- Acronym / sponsor ID
- OPM-G-H-1601
- Conditions
- Therapeutic Irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IryPump R Set | Experimental | Device: IryPump R SetA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with bowel obstruction
- Patient already participating in another clinical study or who have previously participated in this investigation,
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IryPump R Set | Device | IryPump R Set |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Charvier principal investigator
Henry Gabrielle Hospital- St Genis Laval- France
Questions about this trial
What is this clinical trial studying?
A study testing IryPump R Set in people with Therapeutic Irrigation, run by BBraun Medical SAS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.