Bowel DysfunctionNCT05644912
Exploratory Investigation on a Novel Catheter
A study testing Transanal irrigation (TAI) in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Netherlands.
Trial summary
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter. In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- Transanal irrigation (TAI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Nov 2022to 15 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent.
- Female and male aged 18-80 years.
- Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
- Patients considered suitable to participate by investigator.
- Able to read, write and understand information given to them regarding the study.
Who cannot join
- Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
- Previous enrolment in the present clinical investigation.
- Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
- Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
- Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
- Known anal or colorectal stenosis.
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- Active inflammatory bowel disease.
- Acute diverticulitis.
- Colorectal cancer.
- Ischemic colitis.
- Any anal or colorectal surgery within the previous 3 months.
- Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
- Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
- Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
- Conditions
- Bowel Dysfunction
- Being tested
- Transanal irrigation (TAI)
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal irrigation (TAI)Device
Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Transanal irrigation (TAI) with new catheter Receives: Device: Transanal irrigation (TAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter stay in place
Does the catheter stay in place during water instillation? Yes/No
Measured: 1 week
Secondary outcomes (2)
Bowel emptying performance
Evaluation of bowel emptying performance: Subject's perception of emptying of bowel similar to regular use of TAI.
Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study.
Question asked: "What is the subject's perception of emptying of bowel with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better
Measured: 1 week
Leakage
Evaluation of leakage during water instillation: Subject's perception of leakage similar to regular use of TAI.
Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study.
Question asked: "What is the subject's perception of leakage with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start18 Nov 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DysfunctionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingrid Han-Geurts, MD, Principal investigator, Proctos Kliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644912
- Sponsor's protocol ID
- NAV-0010
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD available will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Investigation on a Novel Catheter
- ClinicalTrials.gov ID
- NCT05644912
- Acronym / sponsor ID
- NAV-0010
- Conditions
- Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 9 Dec 2022 (actual)
- 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.
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Transanal irrigation (TAI)Transanal irrigation (TAI) with new catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent.
- Female and male aged 18-80 years.
- Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
- Patients considered suitable to participate by investigator.
- Able to read, write and understand information given to them regarding the study.
Key exclusion criteria (14 listed)
- Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
- Previous enrolment in the present clinical investigation.
- Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
- Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
- Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
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 |
|---|---|---|
| Transanal irrigation (TAI)Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter. | Device | All subjects |
Primary outcome
Catheter stay in place
Time frame: 1 week
Does the catheter stay in place during water instillation? Yes/No
2 secondary outcomes
Bowel emptying performance
Time frame: 1 week
Leakage
Time frame: 1 week
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 24 Apr 2024.
- Individual participant dataSharing planned: No. IPD available will not be available to other researchers.
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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.
Ingrid Han-Geurts, MD principal investigator
Proctos Kliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal irrigation (TAI) in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Netherlands.
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 5 inclusion and 14 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Catheter stay in place (time frame: 1 week). 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 24 Apr 2024.