Investigation of a New Rectal Catheter for Users of Transanal Irrigation

May 28, 2025 updated by: Coloplast A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jutland
      • Århus, Jutland, Denmark, 8200
        • Århus Universitetshospital
    • Zealand
      • Hvidovre, Zealand, Denmark, 2650
        • Amager Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational device - newly developed TAI catheter.
CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
Device: CP362 Test Catheter
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
No Intervention: Peristeen Plus
Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CP362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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