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CompletedNCT01617512Updated Apr 11, 2014

Study Accelerometer Signals to Measure Daily Activities (SASMDA)

An interventional study of LIS302DL accelerometer in Urinary Disorders, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-11.

Sponsored by AdministrateurCIC · Not applicable, Interventional, and Basic science

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Urinary Disorders
03

In context

Lead sponsor

AdministrateurCIC is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • man
  • patients fitted with artificial urinary sphincter
  • patients affiliated to social security or similar regime

Exclusion criteria

Exclusion Criteria:

  • patient do not speak french
  • patient unable to express his consent
  • patient hospitalize without consent
  • patient under legal protection
  • patient deprived of liberty
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • DeviceLIS302DL accelerometer

    Recording for 24 hours accelerations related to daily physical activity of the patient.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 6 months

07

Study locations

1 site
  • University Hospital
    Grenoble, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2011
First posted
Jun 12, 2012
Start
Feb 2012
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Apr 11, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01617512
Lead sponsor
AdministrateurCIC
Collaborators
TIMC-IMAG, Laboratory TIMA, Clinical Investigation Centre for Innovative Technology Network
Responsible party
AdministrateurCIC (principal investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
Jun 12, 2012
Start date
Feb 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Apr 11, 2014

Study contacts

Alexandre Moreau-gaudry, MD, PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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