NCT00626821

Brief Summary

The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,017

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Typical duration for phase_4

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

February 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 12, 2012

Completed
Last Updated

March 12, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

February 21, 2008

Results QC Date

October 6, 2011

Last Update Submit

February 9, 2012

Conditions

Stoma

Keywords

StomaOstomy

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (Scale 0(Worst)-100(Best))

    The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.

    6-8 weeks

Study Arms (1)

1

EXPERIMENTAL
Device: SenSura

Interventions

SenSuraDEVICE

Real life assessment of SenSura

1

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent before any study related activities
  • Subjects with a colostomy, ileostomy or urostomy
  • Subjects must have had their ostomy for at least 6 months
  • Subjects must have mental capacity to understand the study and questionnaires
  • Subjects must be at least 18 years of age.

You may not qualify if:

  • Women who are pregnant or breast-feeding
  • Subjects who have more than one ostomy
  • Subjects with an ostomy who use plug
  • Participation in other studies at the same time
  • Previous participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Restored Images

Kansas City, Missouri, 64119, United States

Location

Results Point of Contact

Title
Helle Aaes Senior Scientific Manager
Organization
Coloplast
dkheaa@coloplast.com
+45 49112949

Study Officials

  • Birgitte D Andersen, RN

    Herlev Hospital, Dep of colorectal surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2010

Study Completion

December 1, 2010

Last Updated

March 12, 2012

Results First Posted

March 12, 2012

Record last verified: 2012-01

Locations

US(1)