Fecal IncontinenceNCT02208258
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
A study testing Consure 120 Stool Management System in people with Fecal Incontinence, run by Consure Medical Pvt. Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Consure 120 Stool Management System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2014
- 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
- Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
- Non-ambulatory, hospitalized patients.
- History of passage of at least 1 stool in 24 hours.
Who cannot join
- Patients with suspected or confirmed rectal mucosal impairment or pathology.
- Patients with have undergone descending colon or rectal surgery within the preceding six months.
- Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
- Patients suspected to have impacted stool or is suffering from constipation.
- Patients with confirmed pregnancy or suspected to be pregnant.
- Patients that have planned MRI examination over the duration of the study.
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- Patients who have suffered recent cardiac arrest within the preceding 3 months.
- Patients enrolled in another clinical study or clinical trial.
- Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.
- Conditions
- Fecal Incontinence
- Being tested
- Consure 120 Stool Management System
- Keywords
- fecal incontinence, consure medical, semi formed stool, stool management system
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consure 120 Stool Management SystemDevice
Also called Consure 120 SMS
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual confirmation that fecal material is diverted into the external collection bag through the device.
Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
Measured: 120 +/- 8 hours
Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
Measured: 120 +/- 8 hours
Number of hours for which the device stays on without change or removal.
Quantitative measure of duration of device use. The cause of the change or removal will be documented.
Measured: 120 +/- 8 hours
Secondary outcomes (1)
Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.
Yes or No response from visual observation of any bleeding on the external periphery of the device.
Measured: 120 +/- 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Hospital had initiated a conflicting study, hence the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consure Medical Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208258
- Sponsor's protocol ID
- CON/2013/FI003
- Status last verified
- Jan 2016
- First submitted
- 1 Aug 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
- ClinicalTrials.gov ID
- NCT02208258
- Acronym / sponsor ID
- CON/2013/FI003
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, consure medical, semi formed stool, stool management system
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hospital had initiated a conflicting study, hence the study was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Consure Medical Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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 purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
- Non-ambulatory, hospitalized patients.
- History of passage of at least 1 stool in 24 hours.
Key exclusion criteria (9 listed)
- Patients with suspected or confirmed rectal mucosal impairment or pathology.
- Patients with have undergone descending colon or rectal surgery within the preceding six months.
- Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
- Patients suspected to have impacted stool or is suffering from constipation.
- Patients with confirmed pregnancy or suspected to be pregnant.
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 |
|---|---|---|
| Consure 120 Stool Management SystemAlso: Consure 120 SMSNovel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool. | Device | – |
Primary outcome
Visual confirmation that fecal material is diverted into the external collection bag through the device.
Time frame: 120 +/- 8 hours
Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
Time frame: 120 +/- 8 hours
Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
Number of hours for which the device stays on without change or removal.
Time frame: 120 +/- 8 hours
Quantitative measure of duration of device use. The cause of the change or removal will be documented.
1 secondary outcome
Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.
Time frame: 120 +/- 8 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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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.
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 Consure 120 Stool Management System in people with Fecal Incontinence, run by Consure Medical Pvt. Ltd. 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 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: withdrawn, as of the sponsor's last update on 29 Jan 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
Visual confirmation that fecal material is diverted into the external collection bag through the device. (time frame: 120 +/- 8 hours). 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 29 Jan 2016.