Comfort and Performance of Intermittent CatheterNCT03387878
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
A study testing Intermittent Catheter in people with Comfort and Performance of Intermittent Catheter, run by ConvaTec Inc. at 1 site in Poland.
Trial summary
To evaluate the performance of GentleCath Glide™ Intermittent Catheters Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comfort and Performance of Intermittent Catheter
- What is being tested?
- Intermittent Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2017to 10 Jan 2018
- 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
- Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
- Subjects must be willing and able to provide written informed consent
- Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
- Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
- Patients who self-catheterise at least three times per day
- Able to attend final assessment visit at day 14
Who cannot join
- Subjects who require intermittent catheterisation to administer irrigation or instillation.
- Subjects who are presently participating in another clinical trial.
- Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- Subjects with known sensitivity to the device components
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
- Being tested
- Intermittent Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent CatheterDevice
Intermittent urinary catheter for bladder drainage
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | This is a single arm study with no comparator Receives: Device: Intermittent Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance/Ease of Use
Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Measured: 14 Days
Ease of Removal
Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Measured: 14 Days
Residue Acceptability
Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
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 posted2 Jan 2018
- Study start1 Jul 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comfort and Performance of Intermittent CatheterStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387878
- Sponsor's protocol ID
- CC-925-17-U378
- Status last verified
- Dec 2022
- First submitted
- 22 Aug 2017
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
- ClinicalTrials.gov ID
- NCT03387878
- Acronym / sponsor ID
- CC-925-17-U378
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 2 Jan 2018 (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.
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Device: Intermittent CatheterThis is a single arm study with no comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
- Subjects must be willing and able to provide written informed consent
- Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
- Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
- Patients who self-catheterise at least three times per day
Key exclusion criteria (4 listed)
- Subjects who require intermittent catheterisation to administer irrigation or instillation.
- Subjects who are presently participating in another clinical trial.
- Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- Subjects with known sensitivity to the device components
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 |
|---|---|---|
| Intermittent CatheterIntermittent urinary catheter for bladder drainage | Device | Single Arm Study |
Primary outcome
Performance/Ease of Use
Time frame: 14 Days
Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Ease of Removal
Time frame: 14 Days
Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Residue Acceptability
Time frame: 14 Days
Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
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 6 Dec 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Catheter in people with Comfort and Performance of Intermittent Catheter, run by ConvaTec Inc. at 1 site in Poland.
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 4 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 6 Dec 2022. 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 Poland. 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/Ease of Use (time frame: 14 Days). The study lists 3 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 6 Dec 2022.