Urinary DisordersNCT01617512
Study Accelerometer Signals to Measure Daily Activities (SASMDA)
A study testing LIS302DL accelerometer in people with Urinary Disorders, run by AdministrateurCIC at 1 site in France.
Trial summary
The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Disorders
- What is being tested?
- LIS302DL accelerometer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jul 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- man
- patients fitted with artificial urinary sphincter
- patients affiliated to social security or similar regime
Who cannot join
- patient do not speak french
- patient unable to express his consent
- patient hospitalize without consent
- patient under legal protection
- patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study
The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.
- Conditions
- Urinary Disorders
- Being tested
- LIS302DL accelerometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIS302DL accelerometerDevice
Recording for 24 hours accelerations related to daily physical activity of the patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.
Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data
Measured: 6 months
Secondary outcomes (1)
Score of satisfaction with the use of the medical device, assessed by the patients
Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary DisordersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Laboratory TIMA, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Alexandre Moreau-gaudry, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617512
- Sponsor's protocol ID
- DCIC 1116
- Status last verified
- Apr 2014
- First submitted
- 15 Dec 2011
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Accelerometer Signals to Measure Daily Activities: a Pilot Study
- ClinicalTrials.gov ID
- NCT01617512
- Acronym / sponsor ID
- DCIC 1116
- Conditions
- Urinary Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Laboratory TIMA, Clinical Investigation Centre for Innovative Technology Network
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jun 2012 (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 determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- man
- patients fitted with artificial urinary sphincter
- patients affiliated to social security or similar regime
Key exclusion criteria (5 listed)
- patient do not speak french
- patient unable to express his consent
- patient hospitalize without consent
- patient under legal protection
- patient deprived of liberty
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 |
|---|---|---|
| LIS302DL accelerometerRecording for 24 hours accelerations related to daily physical activity of the patient. | Device | – |
Primary outcome
Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.
Time frame: 6 months
Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data
1 secondary outcome
Score of satisfaction with the use of the medical device, assessed by the patients
Time frame: 6 months
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 11 Apr 2014.
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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.
Alexandre Moreau-gaudry, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIS302DL accelerometer in people with Urinary Disorders, run by AdministrateurCIC at 1 site in France.
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 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 11 Apr 2014. 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 France. 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?
Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data. (time frame: 6 months). 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 11 Apr 2014.