Ileostomy - StomaNCT05891041
New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon
An observational study of Ileostomy - Stoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Apr 2023to 1 Oct 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients with an ileostoma
Who may be able to join
- Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm
Who cannot join
- Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc
1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.
Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.
Read the detailed description
Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.
The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.
- Conditions
- Ileostomy - Stoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
Safety of Interpoc during use
Measured: 6 hours
Secondary outcomes (9)
Pain during interpoc use
Using the NRS from 0-10
Measured: 6 hours
Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),
A low score is better than a high score
Measured: 6 hours
Scale (0-10) score of Discomfort, acid reflux, nausea
A low score is better than a high score
Measured: 6 hours
InterPoc™ weight before and after insertion
For comparable
Measured: 6 hours
Leakage around the stoma pouch
Scale: 1-3)
Measured: 6 hours
Fecal output in stoma bag (ml) before and after the trail
scale 1-3
Measured: 6 hours
InterPoc™ Skin Irritation
(Scale: 1-3)
Measured: 6 hour
Insertion and removal resistance
scale 1-3)
Measured: 6 hour
Food consumption
descriptive
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start26 Apr 2023
- Primary completion25 Sep 2023
- Study completion1 Oct 2023
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Patrick Achiam, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael P Achiam, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891041
- Sponsor's protocol ID
- H-23000001
- Status last verified
- Dec 2023
- First submitted
- 1 May 2023
- Last updated
- 29 Dec 2023
- Results posted
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc
- ClinicalTrials.gov ID
- NCT05891041
- Acronym / sponsor ID
- H-23000001
- Conditions
- Ileostomy - Stoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 6 Jun 2023 (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.
1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.
Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.
Detailed description
Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.
The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients with an ileostoma
Key inclusion criteria (1 listed)
- Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm
Key exclusion criteria (1 listed)
- Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
Time frame: 6 hours
Safety of Interpoc during use
9 secondary outcomes
Pain during interpoc use
Time frame: 6 hours
Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),
Time frame: 6 hours
Scale (0-10) score of Discomfort, acid reflux, nausea
Time frame: 6 hours
InterPoc™ weight before and after insertion
Time frame: 6 hours
Leakage around the stoma pouch
Time frame: 6 hours
Fecal output in stoma bag (ml) before and after the trail
Time frame: 6 hours
InterPoc™ Skin Irritation
Time frame: 6 hour
Insertion and removal resistance
Time frame: 6 hour
Food consumption
Time frame: 6 hour
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 29 Dec 2023.
- 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.
Michael P Achiam principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileostomy - Stoma, run by Copenhagen University Hospital, Rigshospitalet 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 1 inclusion and 1 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 29 Dec 2023. 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?
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours (time frame: 6 hours). 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 29 Dec 2023.