Ileostomy - StomaNCT06897163
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
A study testing Specialized Absorbent Intestinal Tampon in people with Ileostomy - Stoma, run by Ampa Medical at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Specialized Absorbent Intestinal Tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Dec 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ileostomy > 6 months old
- Stoma opening ≥ 10 mm in diameter
- Written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Method for Ileostomy Output Collection Using an Intestinal Tampon: An Extended Study
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?
Read more
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.
Read the detailed description
Study Overview This study aims to evaluate the feasibility and user acceptance of a specialized absorbent intestinal tampon designed to collect ileostomy output. The study seeks to address the limitations and complications associated with traditional stoma bags, which have been the standard solution since the 1950s.
Background and Rationale Approximately 1 million people worldwide live with an ileostomy, relying on stoma bags to collect liquid stool. Despite innovations in materials and design, stoma bags still cause significant physical and mental discomfort. Issues include the unsightly appearance of the bag, leakage, noise, and skin irritation. These problems can lead to a reduced quality of life and increased healthcare costs due to skin complications.
The specialized absorbent intestinal tampon is hypothesized to be a discreet and effective alternative to stoma bags. It is designed to be self-inserted by the user, absorb liquid stool, and reduce the complications associated with stoma bags. Previous studies have shown that the tampon can be safely inserted by a healthcare professional, and this study aims to determine if users can safely and effectively insert the tampon themselves.
Study Design and Methods The study is a continuation of a proof-of-concept trial with a qualitative design. It involves observing and interviewing participants during the insertion of the tampon, both by a medical consultant and by the participants themselves. The study will test different tampon designs and coatings to find the most suitable one for insertion and retention.
Participants:
10 individuals with ileostomies, previously screened and included in the study. Inclusion criteria: Age ≥ 18 years, ileostomy > 6 months old, written informed consent, stoma opening ≥ 10 mm in diameter.
Exclusion criteria: Difficulty understanding study information, somatic illness, active inflammatory bowel disease, hernia around the stoma, daily output > 2 liters, active inflammation in the ileum.
Procedures:
Day 1:
Participants arrive at the study site. A medical consultant inserts the tampon and observes the participant. Participants then self-insert the tampon under supervision. The procedure is repeated with different tampon designs, up to three times.
Day 2:
Participants self-insert the tampon using the best method from Day 1. Stool samples are collected before and after tampon use for microbiota analysis.
Participants are interviewed about their experience, including any discomfort or pain using a numerical rating scale (NRS).
The tampon remains in place for up to 6 hours, with participants free to move and eat.
The tampon is removed, and another stool sample is collected. Further testing and iterations may be conducted at home with detailed documentation and follow-up interviews.
Data Collection:
Qualitative data from interviews and observations. Quantitative data from NRS scores for pain and discomfort. Microbiota analysis of stool samples before and after tampon use.
Risks and Benefits The study aims to minimize any discomfort or complications associated with the tampon. Previous safety data indicate no serious risks, but participants are trained and supervised during insertion. Potential risks include pain during insertion, expansion, or removal of the tampon, and rare complications such as tampon retention or perforation.
The potential benefits of the study are significant, as the tampon could provide a more discreet and comfortable alternative to stoma bags, improving the quality of life for individuals with ileostomies.
Ethical Considerations The study adheres to ethical guidelines, including informed consent, data protection, and participant safety. Results will be published in a peer-reviewed journal and on the sponsor's website, regardless of the outcome.
Conclusion This study aims to provide valuable insights into the feasibility and user acceptance of a specialized absorbent intestinal tampon for ileostomy patients. By addressing the limitations of traditional stoma bags, the tampon has the potential to significantly improve the quality of life for individuals with ileostomies.
- Conditions
- Ileostomy - Stoma
- Being tested
- Specialized Absorbent Intestinal Tampon
- Keywords
- Ileostomy, Stoma care, Stoma management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Absorbent Intestinal TamponDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Specialized Absorbent Intestinal Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and Day 2 of the study
Secondary outcomes (2)
Level of Discomfort or Pain During Insertion and Use
This measure will evaluate the level of discomfort or pain experienced by participants during the insertion and use of the intestinal tampon. Participants will rate their pain using a numerical rating scale (NRS) from 0 to 10.
Measured: Day 2 of the study
Changes in Microbiota Composition
This measure will analyze changes in the microbiota composition of stool samples collected before and after using the intestinal tampon. The analysis will focus on the relative abundance of different bacterial species.
Measured: Before and after tampon use on Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start10 Dec 2024
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampa Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cecilie Ammitzbøll, Ampa Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897163
- Sponsor's protocol ID
- H-23000001
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Ileostomy Output Collection Using an Intestinal Tampon: An Extended Study
- ClinicalTrials.gov ID
- NCT06897163
- Acronym / sponsor ID
- H-23000001
- Conditions
- Ileostomy - Stoma
- Keywords
- Ileostomy, Stoma care, Stoma management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ampa MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Overview This study aims to evaluate the feasibility and user acceptance of a specialized absorbent intestinal tampon designed to collect ileostomy output. The study seeks to address the limitations and complications associated with traditional stoma bags, which have been the standard solution since the 1950s.
Background and Rationale Approximately 1 million people worldwide live with an ileostomy, relying on stoma bags to collect liquid stool. Despite innovations in materials and design, stoma bags still cause significant physical and mental discomfort. Issues include the unsightly appearance of the bag, leakage, noise, and skin irritation. These problems can lead to a reduced quality of life and increased healthcare costs due to skin complications.
The specialized absorbent intestinal tampon is hypothesized to be a discreet and effective alternative to stoma bags. It is designed to be self-inserted by the user, absorb liquid stool, and reduce the complications associated with stoma bags. Previous studies have shown that the tampon can be safely inserted by a healthcare professional, and this study aims to determine if users can safely and effectively insert the tampon themselves.
Study Design and Methods The study is a continuation of a proof-of-concept trial with a qualitative design. It involves observing and interviewing participants during the insertion of the tampon, both by a medical consultant and by the participants themselves. The study will test different tampon designs and coatings to find the most suitable one for insertion and retention.
Participants:
10 individuals with ileostomies, previously screened and included in the study. Inclusion criteria: Age ≥ 18 years, ileostomy > 6 months old, written informed consent, stoma opening ≥ 10 mm in diameter.
Exclusion criteria: Difficulty understanding study information, somatic illness, active inflammatory bowel disease, hernia around the stoma, daily output > 2 liters, active inflammation in the ileum.
Procedures:
Day 1:
Participants arrive at the study site. A medical consultant inserts the tampon and observes the participant. Participants then self-insert the tampon under supervision. The procedure is repeated with different tampon designs, up to three times.
Day 2:
Participants self-insert the tampon using the best method from Day 1. Stool samples are collected before and after tampon use for microbiota analysis.
Participants are interviewed about their experience, including any discomfort or pain using a numerical rating scale (NRS).
The tampon remains in place for up to 6 hours, with participants free to move and eat.
The tampon is removed, and another stool sample is collected. Further testing and iterations may be conducted at home with detailed documentation and follow-up interviews.
Data Collection:
Qualitative data from interviews and observations. Quantitative data from NRS scores for pain and discomfort. Microbiota analysis of stool samples before and after tampon use.
Risks and Benefits The study aims to minimize any discomfort or complications associated with the tampon. Previous safety data indicate no serious risks, but participants are trained and supervised during insertion. Potential risks include pain during insertion, expansion, or removal of the tampon, and rare complications such as tampon retention or perforation.
The potential benefits of the study are significant, as the tampon could provide a more discreet and comfortable alternative to stoma bags, improving the quality of life for individuals with ileostomies.
Ethical Considerations The study adheres to ethical guidelines, including informed consent, data protection, and participant safety. Results will be published in a peer-reviewed journal and on the sponsor's website, regardless of the outcome.
Conclusion This study aims to provide valuable insights into the feasibility and user acceptance of a specialized absorbent intestinal tampon for ileostomy patients. By addressing the limitations of traditional stoma bags, the tampon has the potential to significantly improve the quality of life for individuals with ileostomies.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specialized Absorbent Intestinal Tampon Group | Experimental | Device: Specialized Absorbent Intestinal TamponParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Ileostomy > 6 months old
- Stoma opening ≥ 10 mm in diameter
- Written informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized Absorbent Intestinal TamponThe 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. | Device | Specialized Absorbent Intestinal Tampon Group |
Primary outcome
Feasibility of Self-Insertion of the Intestinal Tampon
Time frame: Day 1 and Day 2 of the study
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.
2 secondary outcomes
Level of Discomfort or Pain During Insertion and Use
Time frame: Day 2 of the study
Changes in Microbiota Composition
Time frame: Before and after tampon use on Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Absorbent Intestinal Tampon in people with Ileostomy - Stoma, run by Ampa Medical at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Self-Insertion of the Intestinal Tampon (time frame: Day 1 and Day 2 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.