Stoma IleostomyNCT04715893
Ostomy Belt Use Associated Quality of Life
A study testing Ostomy belt in people with Stoma Ileostomy and Stoma Colostomy, run by University of Miami at 1 site in United States.
Trial summary
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Ostomy belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 28 Feb 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
- 18 - 70 years old
- Willing and able to sign informed consent
Who cannot join
- Patients without stoma or unwilling to wear ostomy belt.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Being tested
- Ostomy belt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy beltOther
Stealth ostomy belt continuous for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Ostomy belt group | Experimental | Participants in this group will receive ostomy belts for eight weeks. Receives: Other: Ostomy belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life as measured by SQOLS
Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.
Measured: Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Feb 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Hui, University of Miami
- Investigators
- Vanessa Hui, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715893
- Sponsor's protocol ID
- 20201333
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2021
- Last updated
- 17 Jan 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ostomy Belt Use Associated Quality of Life
- ClinicalTrials.gov ID
- NCT04715893
- Acronym / sponsor ID
- 20201333
- Conditions
- Stoma Ileostomy, Stoma Colostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 20 Jan 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.
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostomy belt group | Experimental | Other: Ostomy beltParticipants in this group will receive ostomy belts for eight weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
- 18 - 70 years old
- Willing and able to sign informed consent
Key exclusion criteria (2 listed)
- Patients without stoma or unwilling to wear ostomy belt.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
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 beltStealth ostomy belt continuous for eight weeks | Other | Ostomy belt group |
Primary outcome
Change in quality of life as measured by SQOLS
Time frame: Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use
Quality of life will be assessed using the Stoma Quality of Life Scale questionnaire (SQOLS) with a range in score from 0 to 100 in overall satisfaction in life with a higher score indicating higher satisfaction.
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 17 Jan 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.
Vanessa Hui, MD principal investigator
University of Miami
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 belt in people with Stoma Ileostomy and Stoma Colostomy, run by University of Miami 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 3 inclusion and 2 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 17 Jan 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 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 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?
Change in quality of life as measured by SQOLS (time frame: Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use). 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 17 Jan 2025.