A New Method for Ileostomy Output Collection Using an Intestinal Tampon

NCT06897163 | Completed

• 1 other identifier: H-23000001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ileostomy; Stoma care; Stoma management

Outcome Measures

Primary Outcomes (1)

• Feasibility of Self-Insertion of the Intestinal Tampon

  This measure will assess the feasibility of self-inserting the specialized absorbent intestinal tampon. Feasibility will be determined by the percentage of successful insertions, as well as participant feedback and medical consultant observations, which will be reported separately.

  Day 1 and Day 2 of the study

Secondary Outcomes (2)

• Level of Discomfort or Pain During Insertion and Use

  Day 2 of the study

• Changes in Microbiota Composition

  Before and after tampon use on Day 2

Study Arms (1)

Specialized Absorbent Intestinal Tampon Group

EXPERIMENTAL

Participants in this arm will receive the specialized absorbent intestinal tampon designed to collect ileostomy output. The study will evaluate the feasibility, safety, and user acceptance of the tampon.

Device: Specialized Absorbent Intestinal Tampon

Interventions

Specialized Absorbent Intestinal Tampon DEVICE

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.

Specialized Absorbent Intestinal Tampon Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Ileostomy \> 6 months old
• Stoma opening ≥ 10 mm in diameter
• Written informed consent

You may not qualify if:

• Difficulty understanding study information, including language barriers
• Somatic illness, including active inflammatory bowel disease
• Hernia around the stoma
• Daily output \> 2 liters
• Active inflammation in the ileum (diagnosed within 2 months before the study day)

Sponsors & Collaborators

• Ampa Medical: lead

Study Sites (1)

Ampa Medical

Copenhagen, 1620, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor (MD, PhD)

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: March 26, 2025
• Study Start: December 10, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)