Exploratory Investigation on a Novel Catheter

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 Overview

• Status: Completed
• Conditions: Bowel Dysfunction
• Intervention / Treatment: Device: Transanal irrigation (TAI)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • MB Bilthoven
    • Bilthoven, MB Bilthoven, Netherlands, 3723
      • Proctos Kliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; Transanal irrigation (TAI) with new catheter	Device: Transanal irrigation (TAI); Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter stay in place	Does the catheter stay in place during water instillation? Yes/No	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Ingrid Han-Geurts, MD, Proctos Kliniek

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: NAV-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD available will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No