Colostomy StomaNCT05466721
Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
A study testing Hydrustoma C3 and Coloplast Alterna in people with Colostomy Stoma, run by Hydrumedical at 6 sites in Portugal.
Trial summary
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colostomy Stoma
- What is being tested?
- Hydrustoma C3 and Coloplast Alterna
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesPortugal
- Study dates
- 13 Jun 2022to 31 Dec 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent;
- Male and Female patients;
- Adult aged ≥ 18;
- Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
- Having formed stool and using a flat ostomy appliance;
- Able to understand the study procedures and fill questionaries;
- Able to apply and remove the ostomy device autonomously.
Who cannot join
- Repeated experiences of leakage with the usual ostomy device,
- Chronically liquid stools,
- Peristomal skin disorders,
- Known allergic reactions to components of the device,
- Receiving chemotherapy, radiation therapy or steroids in the previous month
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Portugal6 sites
Hospital de Braga
Braga, 4710
Hospital Da Senhora Da Oliveira - Guimarães
Guimarães, Braga District, 4835
Centro Hospitalar do Tâmega e Sousa
Penafiel, 4560
Centro Hospitalar de Entre o Douro e Vouga
Santa Maria da Feira, 4520
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4430
Centro Hospitalar de Trás-os-Montes e Alto Douro
Vila Real, 5000
About this study
Official title: HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.
The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
- Conditions
- Colostomy Stoma
- Being tested
- Hydrustoma C3, Coloplast Alterna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrustoma C3Device
The participant will use the device for 14 days.
Coloplast AlternaDevice
The participant will use the device for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Hydrustoma C3 | Experimental | The participant will use the Hydrustoma C3 devices for 14 days and then switch into the control device for another 14 days. Receives: Device: Hydrustoma C3; Device: Coloplast Alterna |
| Coloplast Alterna | Other | The participant will use the control devices for 14 days and then switch into the Hydrustoma C3 devices for another 14 days. Receives: Device: Hydrustoma C3; Device: Coloplast Alterna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the device (journal of capsule/bag changes)
Efficacy will be accessed by asking patients to record on a journal/diary, for each capsule/bag change, what was the reason for the change, and the occurrence and level of leakage.
Measured: 14 days
Quality of life of the participant (Stoma Quality of Life questionnaire)
In order to compare stoma related quality of life in patients with colostomy when using a control device and the Hydrustoma C3 devices the Stoma Quality of Life questionnaire will be used. This questionnaire is composed of 20 questions. Example of question "I worry that the bag detaches.". All questions must be answered on a scale of 1 to 4, being 1 always and 4 never.
Measured: 14 days
Adverse effects
Safety evaluations will be done by monitoring adverse events.
Measured: 14 days
Safety of the device (Discolouration, Erosion, Tissue overgrowth score)
Safety evaluations will be done by monitoring the peristomal skin using the validated Ostomy Skin tool (DET score). The DET Score is calculated by examining the peristomal skin and evaluate the skin based on the descriptions in each of the 3 domains, discolouration (D), erosion (E) and tissue overgrowth (T); and assessing the size of the area affected in each of the 3 domains. The total score is (maximum 15) calculated by adding all of the subscores from each domain together.
Measured: 14 days
Secondary outcomes (1)
Satisfaction of the participant (questionnaire)
The patients will be asked to evaluate the medical device in terms of application, discretion of the device, stoma related noise, feelings of security (confidence) and overall satisfaction of use (including comfort and impact on body image). The questionnaire has 8 questions of multiple choice (example "Regarding the safety during usage of the devices, I feel: (1) very insecure; (2) moderately insecure; (3) Moderadately secure; (4) Very secure") and 1 open answer question.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start13 Jun 2022
- Primary completion19 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hydrumedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Palmira Peixoto, Principal investigator, Hospital de BragaPaula Costa, Principal investigator, Hospital Da Senhora Da Oliveira - GuimarãesLiliana Miranda, Principal investigator, Hospital Centre Hospitalar de Trás-os-Montes e Alto DouroSara Costa, Principal investigator, Centro Hospitalar de Entre o Douro e VougaGlória Gonçalves, Principal investigator, Centro Hospitalar de Vila Nova de Gaia/EspinhoCarla Nunes, Principal investigator, Centro Hospitalar do Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466721
- Sponsor's protocol ID
- HydrustomaC3
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
- ClinicalTrials.gov ID
- NCT05466721
- Acronym / sponsor ID
- HydrustomaC3
- Conditions
- Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- HydrumedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Jul 2022 (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 surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.
The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrustoma C3 | Experimental | Device: Hydrustoma C3, Device: Coloplast AlternaThe participant will use the Hydrustoma C3 devices for 14 days and then switch into the control device for another 14 days. |
| Coloplast Alterna | Other | Device: Hydrustoma C3, Device: Coloplast AlternaThe participant will use the control devices for 14 days and then switch into the Hydrustoma C3 devices for another 14 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent;
- Male and Female patients;
- Adult aged ≥ 18;
- Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
- Having formed stool and using a flat ostomy appliance;
Key exclusion criteria (5 listed)
- Repeated experiences of leakage with the usual ostomy device,
- Chronically liquid stools,
- Peristomal skin disorders,
- Known allergic reactions to components of the device,
- Receiving chemotherapy, radiation therapy or steroids in the previous month
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 |
|---|---|---|
| Hydrustoma C3The participant will use the device for 14 days. | Device | Coloplast Alterna, Hydrustoma C3 |
| Coloplast AlternaThe participant will use the device for 14 days. | Device | Coloplast Alterna, Hydrustoma C3 |
Primary outcome
Efficacy of the device (journal of capsule/bag changes)
Time frame: 14 days
Efficacy will be accessed by asking patients to record on a journal/diary, for each capsule/bag change, what was the reason for the change, and the occurrence and level of leakage.
Quality of life of the participant (Stoma Quality of Life questionnaire)
Time frame: 14 days
In order to compare stoma related quality of life in patients with colostomy when using a control device and the Hydrustoma C3 devices the Stoma Quality of Life questionnaire will be used. This questionnaire is composed of 20 questions. Example of question "I worry that the bag detaches.". All questions must be answered on a scale of 1 to 4, being 1 always and 4 never.
Adverse effects
Time frame: 14 days
Safety evaluations will be done by monitoring adverse events.
Safety of the device (Discolouration, Erosion, Tissue overgrowth score)
Time frame: 14 days
Safety evaluations will be done by monitoring the peristomal skin using the validated Ostomy Skin tool (DET score). The DET Score is calculated by examining the peristomal skin and evaluate the skin based on the descriptions in each of the 3 domains, discolouration (D), erosion (E) and tissue overgrowth (T); and assessing the size of the area affected in each of the 3 domains. The total score is (maximum 15) calculated by adding all of the subscores from each domain together.
1 secondary outcome
Satisfaction of the participant (questionnaire)
Time frame: 14 days
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 18 Jan 2024.
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The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
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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.
Palmira Peixoto principal investigator
Hospital de Braga
Paula Costa principal investigator
Hospital Da Senhora Da Oliveira - Guimarães
Liliana Miranda principal investigator
Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrustoma C3 and Coloplast Alterna in people with Colostomy Stoma, run by Hydrumedical at 6 sites in Portugal.
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 7 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal. 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?
Efficacy of the device (journal of capsule/bag changes) (time frame: 14 days). The study lists 4 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 18 Jan 2024.