Exploratory Investigation on a Novel Catheter

Recruiting

• Conditions: bowel dysfunction; Transanal irrigation; 10002112

• Registration Number: NL-OMON53534
• Lead Sponsor: Wellspect HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Yes / No confirmation if catheter stay in place during water<br /><br>instillation by assessment of expulsion of catheter.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint: Emptying of bowel similar to regular use of Navina Smart<br /><br>system & Leakage similar to regular use of Navina Smart system.</p><br>