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A New Method for Ileostomy Output Collection Using an Intestinal Tampon

NCT06897163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-05

No results posted yet for this study

Summary

The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output. The main questions it aims to answer are:

* Can participants successfully self-insert the intestinal tampon?
* What is the level of discomfort or pain associated with the insertion and use of the tampon?

Researchers will compare different tampon designs and coatings to find the most suitable one for insertion and retention. Participants will:

* Be observed and interviewed during the insertion of the tampon by a medical consultant.
* Self-insert the tampon under supervision and later independently.
* Provide feedback on their experience, including any discomfort or pain using a numerical rating scale (NRS).
* Provide stool samples before and after using the tampon for microbiome analysis.

This study aims to determine the feasibility and user acceptance of the intestinal tampon as an alternative to traditional stoma bags, potentially reducing complications and improving the quality of life for people with an ileostomy.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Specialized Absorbent Intestinal Tampon

The specialized absorbent intestinal tampon is designed to be self-inserted by participants with ileostomies. It aims to collect ileostomy output and improve the quality of life by reducing complications associated with traditional stoma bags. The study will test different tampon designs and coatings to find the most suitable one for insertion and retention. Participants will be observed and interviewed during the insertion process, and their feedback on discomfort or pain will be collected using a numerical rating scale (NRS). Stool samples will be collected before and after tampon use for microbiota analysis.

Sponsors & Collaborators

  • Ampa Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2025-07-31
Completion
2025-08-31

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 NCT06897163 on ClinicalTrials.gov