Stoma Site LeakageOstoRingNCT04802538
Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management
A study testing OstoRing® in people with Stoma Site Leakage, run by Endeavor Health at 1 site in United States.
Trial summary
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Site Leakage
- What is being tested?
- OstoRing®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2020to 4 Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age and have full legal capacity
- Have had an end or loop ileostomy or colostomy for at least 6 months.
- Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
- Able to provide informed consent
- Have a stoma with a diameter of 57mm or less
- Change their pouching system at least two times in seven days
Who cannot join
- Unable to give informed consent.
- Are pregnant or currently breastfeeding.
- In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
- In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
- Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
- Currently suffering from a peristomal hernia.
Show all 9Show fewer
- Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
- In the last 30 days has participated or is currently participating in a clinical study
- Assessed with an ostomy skin tool score of ≥3
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, 60201
About this study
Official title: A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
Read the detailed description
In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.
- Conditions
- Stoma Site Leakage
- Being tested
- OstoRing®
- Keywords
- ileostomy, colostomy, stoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OstoRing®Device
Participants will use the OstoRing® along with their standard pouching equipment.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days. Receives: Device: OstoRing® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouching Equipment Wear Time/Lifespan
Mean pouching system wear time will be calculated with and without the OstoRing®.
Measured: 75 days
Coloplast Tool Skin Assessment Score
The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area.
Measured: 75 days
Secondary outcomes (1)
City of Hope Quality of Life Ostomy Questionnaire Score
Quality of life will be assessed at all study visits utilizing the City of Hope Quality of Life Ostomy Questionnaire. This instrument contains 43 questions with answers on a Likert scale from 1 to 10. The final score is the sum of all responses divided by the total number questions which gives a final score from 1 to 10. Greater score on this survey is indicative of a better quality of life.
Measured: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start6 Nov 2020
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Why it stopped: Sponsor decided to terminate study due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Site LeakageStudies 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
- Model description
- Early feasibility device study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene F Yen, MD, MBA, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802538
- Sponsor's protocol ID
- EH19-278
- Acronym
- OstoRing
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management
- ClinicalTrials.gov ID
- NCT04802538
- Acronym / sponsor ID
- OstoRing / EH19-278
- Conditions
- Stoma Site Leakage
- Keywords
- ileostomy, colostomy, stoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate study due to insufficient recruitment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 17 Mar 2021 (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.
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
Detailed description
In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Early feasibility device study
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: OstoRing®All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 18 years of age and have full legal capacity
- Have had an end or loop ileostomy or colostomy for at least 6 months.
- Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
- Able to provide informed consent
- Have a stoma with a diameter of 57mm or less
Key exclusion criteria (9 listed)
- Unable to give informed consent.
- Are pregnant or currently breastfeeding.
- In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
- In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
- Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
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 |
|---|---|---|
| OstoRing®Participants will use the OstoRing® along with their standard pouching equipment. | Device | Study Group |
Primary outcome
Pouching Equipment Wear Time/Lifespan
Time frame: 75 days
Mean pouching system wear time will be calculated with and without the OstoRing®.
Coloplast Tool Skin Assessment Score
Time frame: 75 days
The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area.
1 secondary outcome
City of Hope Quality of Life Ostomy Questionnaire Score
Time frame: 75 days
Results and safety
The study was stopped early (reason given: Sponsor decided to terminate study due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Eugene F Yen, MD, MBA principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OstoRing® in people with Stoma Site Leakage, run by Endeavor Health at 1 site in United States.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 Apr 2024. 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 States. 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 was stopped early (reason given: Sponsor decided to terminate study due to insufficient recruitment.). Results are not available in the source record.
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?
Pouching Equipment Wear Time/Lifespan (time frame: 75 days). The study lists 2 primary outcomes in all. 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 24 Apr 2024.