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Exploratory Investigation on a Novel Catheter

NCT05644912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Bowel Dysfunction

Interventions

DEVICE

Transanal irrigation (TAI)

Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Ingrid Han-Geurts, MD · Proctos Kliniek

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Netherlands

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 NCT05644912 on ClinicalTrials.gov