Colostomy StomaOUTFLOWNCT06394115
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
An observational study of Colostomy Stoma and Ileostomy - Stoma, run by ConvaTec Inc. at 2 sites in United States.
Trial summary
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colostomy Stoma, Ileostomy - Stoma
- What is being tested?
- Ostomy pouch
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2022to 19 Jun 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A minimum of 15 colostomy and minimum of 10 ileostomies
Who may be able to join
- • Subjects with a colostomy or ileostomy
- Age 18 years and over
- Medically stable in the opinion of the investigator
- Are able and willing to provide informed consent
- Are able and willing to attend study visits
- Currently use the same models of pouches as required by the study
Show all 9Show fewer
- Have a recent history of frequent pancaking (colostomy patients only)
- Willing to stop using any lubricants in the pouches whilst participating in the study.
- Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device.
Who cannot join
- • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment
- Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period.
- Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Princeton Consumer Research
Raritan, New Jersey, 08869
Princeton Consumer Research
St. Petersburg, Florida, 33702
About this study
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma
- Being tested
- Ostomy pouch
- Keywords
- Ileostomy, Colostomy, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy pouchDevice
Ostomy pouch coated with novel technology
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Convatec ostomy pouches which have the novel coating
To demonstrate the performance of Convatec ostomy pouches which have the novel coating
Measured: 16 days
Secondary outcomes (1)
to investigate the safety of Convatec Ostomy Pouches modified with a novel coating
Evaluation of device related safety events during the treatment period and Evaluation of quality of life and patient perception of product.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Aug 2022
- Primary completion30 Mar 2023
- Study completion19 Jun 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394115
- Sponsor's protocol ID
- OC-21-419
- Acronym
- OUTFLOW
- Status last verified
- Apr 2024
- First submitted
- 22 Jul 2022
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
- ClinicalTrials.gov ID
- NCT06394115
- Acronym / sponsor ID
- OUTFLOW / OC-21-419
- Conditions
- Colostomy Stoma, Ileostomy - Stoma
- Keywords
- Ileostomy, Colostomy, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Collaborators
- Princeton Consumer Research
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 1 May 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.
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 15 colostomy and minimum of 10 ileostomies
Key inclusion criteria (9 listed)
- • Subjects with a colostomy or ileostomy
Key exclusion criteria (3 listed)
- • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment
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 pouchOstomy pouch coated with novel technology | Device | – |
Primary outcome
Performance of Convatec ostomy pouches which have the novel coating
Time frame: 16 days
To demonstrate the performance of Convatec ostomy pouches which have the novel coating
1 secondary outcome
to investigate the safety of Convatec Ostomy Pouches modified with a novel coating
Time frame: 16 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 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Colostomy Stoma
RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Ileostomy - Stoma, Colostomy - Stoma
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colostomy Stoma and Ileostomy - Stoma, run by ConvaTec Inc. at 2 sites 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 9 inclusion and 3 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Performance of Convatec ostomy pouches which have the novel coating (time frame: 16 days). 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 1 May 2024.