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Investigation of a New Rectal Catheter for Users of Transanal Irrigation

NCT06389396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-12

Study results available
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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.

Conditions

  • Bowel Management

Interventions

DEVICE

CP362 Test Catheter

The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389396 on ClinicalTrials.gov