OstomyNCT06547905
Evaluation of an Ostomy Leakage Detection System
A study testing Ostomy Leakage Detection System in people with Ostomy, run by Hollister Incorporated at 1 site in United Kingdom.
Trial summary
This study will evaluate the safety and efficacy of an ostomy leakage detection system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- What is being tested?
- Ostomy Leakage Detection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2024to 15 Nov 2024
- 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
- 18 years or Older
- Currently resides in the United Kingdom
- Has an ileostomy, colostomy, or urostomy
- Has a stoma diameter within the following range: 15 mm - 70 mm
- Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).
- Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days
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- Willing to use their typical ostomy pouching system together with the study product for duration of study
- Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS):
- a. Android Devices:
- i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel
- ii. Operating System: Android OS 9.0 (Pie) and later
- b. Apple iPhones:
- i. Compatible Models: iPhone X and later
- ii. Operating System: iPhone Operating System (iOS) 15 and newer
- Is willing to download the phone application for use during the study
- Is willing to follow protocol procedures, as indicated by signing the informed consent
- Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)
Who cannot join
- Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
- Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
- Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
- Reports as legally blind and/or deaf
- Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
- Subject reports currently having an abdominal fistula or abdominal wound
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- Subject has more than one stoma
- Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
- Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility.
- Is currently involved in another research study involving use of ostomy study products or accessories
- Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park
Cambridge, Cambridgeshire, CB21 6GQ
About this study
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
Read the detailed description
Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.
- Conditions
- Ostomy
- Being tested
- Ostomy Leakage Detection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy Leakage Detection SystemDevice
A system that is used to detect ostomy leaks
| Study group | Role | What they receive |
|---|---|---|
| Leakage Detection System arm | Experimental | Participants will utilize the leakage detection system Receives: Device: Ostomy Leakage Detection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Accuracy of the Leakage Detection System (LDS)
The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.
Measured: through study completion, approximately 1 month
Secondary outcomes (5)
How adherent subjects are to leakage notifications (ratio)
The proportion of barriers that are changed due to accurate leakage notifications will yield insights into how adherent subjects are to leakage notifications.
Measured: through study completion, approximately 1 month
How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)
The ratio of the number of times subjects were alerted to leakage prior to a CL occurring to the number of times a barrier change was associated with a Catastrophic leak
Measured: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool
QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OLI which is scored on a scale of 0-100 with higher scores indicating better outcomes
Measured: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool
QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OAI-23 which is scored on a scale of 0-92 with higher scores indicating better outcomes
Measured: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool
QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the SQS which is scored on a scale of 0-10 with higher scores indicating better outcomes
Measured: through study completion, approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start24 Jul 2024
- Primary completion30 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Hugill, Principal investigator, Dansac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547905
- Sponsor's protocol ID
- 6028-OST
- Status last verified
- Mar 2025
- First submitted
- 14 Jun 2024
- Last updated
- 13 Mar 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Ostomy Leakage Detection System
- ClinicalTrials.gov ID
- NCT06547905
- Acronym / sponsor ID
- 6028-OST
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 9 Aug 2024 (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.
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
Detailed description
Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leakage Detection System arm | Experimental | Device: Ostomy Leakage Detection SystemParticipants will utilize the leakage detection system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years or Older
- Currently resides in the United Kingdom
- Has an ileostomy, colostomy, or urostomy
- Has a stoma diameter within the following range: 15 mm - 70 mm
- Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).
Key exclusion criteria (11 listed)
- Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
- Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
- Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
- Reports as legally blind and/or deaf
- Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
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 |
|---|---|---|
| Ostomy Leakage Detection SystemA system that is used to detect ostomy leaks | Device | Leakage Detection System arm |
Primary outcome
The Accuracy of the Leakage Detection System (LDS)
Time frame: through study completion, approximately 1 month
The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.
5 secondary outcomes
How adherent subjects are to leakage notifications (ratio)
Time frame: through study completion, approximately 1 month
How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)
Time frame: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool
Time frame: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool
Time frame: through study completion, approximately 1 month
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool
Time frame: through study completion, approximately 1 month
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 13 Mar 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.
Mary Hugill principal investigator
Dansac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostomy Leakage Detection System in people with Ostomy, run by Hollister Incorporated at 1 site in United Kingdom.
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 17 inclusion and 11 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 13 Mar 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 United Kingdom. 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?
The Accuracy of the Leakage Detection System (LDS) (time frame: through study completion, approximately 1 month). 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 13 Mar 2025.