Clinical trial NCT05644912: Exploratory Investigation on a Novel Catheter
Official title: Exploratory Investigation on a Novel Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Dysfunction
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent.
2. Female and male aged 18-80 years.
3. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
4. Patients considered suitable to participate by investigator.
5. Able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

1. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
2. Previous enrolment in the present clinical investigation.
3. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
4. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
5. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
6. Known anal or colorectal stenosis.
7. Active inflammatory bowel disease.
8. Acute diverticulitis.
9. Colorectal cancer.
10. Ischemic colitis.
11. Any anal or colorectal surgery within the previous 3 months.
12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
13. Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
14. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.

Primary outcomes:
measure: Catheter stay in place
timeFrame: 1 week
Secondary outcomes:
measure: Bowel emptying performance
timeFrame: 1 week
measure: Leakage
timeFrame: 1 week
Other outcomes:
measure: Safety: Adverse Events and Device Deficiencies
timeFrame: 1 week
Locations:
city: Bilthoven
country: Netherlands
facility: Proctos Kliniek
state: MB Bilthoven
Study officials:
affiliation: Proctos Kliniek
name: Ingrid Han-Geurts, MD
role: PRINCIPAL_INVESTIGATOR
References: