Exploratory Investigation on a Novel Catheter

Bowel Dysfunction Clinical Trial

Official title:

Exploratory Investigation on a Novel Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644912
• Other study ID #: NAV-0010
• Status: Completed
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2023
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases

Intervention

Device:
• Transanal irrigation (TAI)
Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.

Locations

Country	Name	City	State
Netherlands	Proctos Kliniek	Bilthoven	MB Bilthoven

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: Adverse Events and Device Deficiencies	To evaluate the safety of catheter by assessment of incidence and severity of Adverse Events (AEs, SAEs, ADEs, SADEs, USADEs) and Device Deficiencies occurring during the study period.	1 week
Primary	Catheter stay in place	Does the catheter stay in place during water instillation? Yes/No	1 week
Secondary	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	1 week
Secondary	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	1 week