---
title: Investigation of a New Rectal Catheter for Users of Transanal Irrigation
nct_id: NCT06389396
overall_status: COMPLETED
phase: NA
sponsor: Coloplast A/S
study_type: INTERVENTIONAL
primary_condition: Bowel Management
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06389396.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06389396"
ct_last_update_post_date: 2025-06-12
last_seen_at: "2026-05-12T07:00:24.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Investigation of a New Rectal Catheter for Users of Transanal Irrigation

**NCT ID:** [NCT06389396](https://clinicaltrials.gov/study/NCT06389396)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Coloplast A/S
- **Conditions:** Bowel Management
- **Start Date:** 2024-04-08
- **Completion Date:** 2024-07-30
- **CT.gov Last Update:** 2025-06-12

## Brief Summary

The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.

The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Has given written Informed Consent
2. Is at least 18 years old
3. Has full legal capacity
4. Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
5. Performs TAI minimum 3 times/week
6. Is able to follow study procedures assessed by investigator

Exclusion Criteria:

1. Has known anal or colorectal stenosis
2. Has active/recurrent colorectal cancer
3. Is within 3 months of anal or colorectal surgery
4. Is within 4 weeks of endoscopic polypectomy
5. Has ischaemic colitis
6. Has acute inflammatory bowel disease
7. Has acute diverticulitis
8. Is participating in any other clinical study that may interfere with this study (assessed by investigator).
9. Is pregnant or breastfeeding
```

## Arms

- **Investigational device - newly developed TAI catheter.** (EXPERIMENTAL) — CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
- **Peristeen Plus** (NO_INTERVENTION) — Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.

## Interventions

- **CP362 Test Catheter** (DEVICE) — The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.

## Primary Outcomes

- **Was it Possible to Perform Transanal Irrigation?** _(time frame: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days))_ — After visit 1 and visit 2, the primary endpoint, defined as if it was possible to perform transanal irrigation, was answered by a yes/no answer.

## Locations (2)

- Århus Universitetshospital, Aarhus, Jutland, Denmark
- Amager Hvidovre Hospital, Hvidovre, Region Sjælland, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.århus universitetshospital|aarhus|jutland|denmark` — added _(2026-05-12)_
- `locations.amager hvidovre hospital|hvidovre|region sjælland|denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06389396.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06389396*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*