NCT02911051

Brief Summary

The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

September 20, 2016

Last Update Submit

January 23, 2018

Conditions

Intermittent Urethral Catheterization

Outcome Measures

Primary Outcomes (1)

  • Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence

    All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered.

Study Arms (1)

Actreen Hydrolite Cath

EXPERIMENTAL

a new hydrophilic coated catheter for Urinary Intermittent Catheterisation

Device: Actreen Hydrolite Cath

Interventions

Actreen Hydrolite CathDEVICE

Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day

Actreen Hydrolite Cath

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male patient
  • patient is at least 18 years old
  • patient having normal or impaired sensation in the urethra
  • patient catheterizing at least 4 times a day
  • patient using Ch 12 or 14 catheter for self clean urinary catheterization
  • patient using a Nelaton catheter for self clean urinary catheterization
  • patient using self clean urinary catheterization for at least one month
  • patient covered with social insurance

You may not qualify if:

  • patient with urethral hypersensitivity
  • patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure
  • patient already participating in another clinical study or who have previously participated in this investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chartier-Kastler

Garches, 92380, France

Location

Study Officials

  • Chartier-Kastler Emmanuel

    Hôspital Raymond Poincaré - Garches

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 22, 2016

Study Start

September 2, 2016

Primary Completion

May 3, 2017

Study Completion

May 3, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)