Condition category
Urological and Genital Diseases
Date applied
11/01/2007
Date assigned
25/01/2007
Last edited
25/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Christina Schönborg

ORCID ID

Contact details

Gambro
Clinical Affairs
Krokslätts Fabriker 32
Mölndal
SE-431 37
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1443

Study information

Scientific title

Acronym

Study hypothesis

Evaluate patient satisfaction in a first filed utilisation before final desicion on product design.

Ethics approval

Ethics Committee at San Marino University Hospital in Genova , approved on 19/07/2006, ref: 0037753/06

Study design

Open, controlled, single center, comparative prospective pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

ESRD - End Stage Renal Disease

Intervention

Tested products: twist extension line combined with twist female connector on Gambrosol trio.

Reference products: current patient line (PDL 1201-8) and current Gambro CAPD system.
All patients will be treated in a CAPD program exchangning Gambrosol trio GEM 20U03 Ca 2,5 with twist for 3 to 5 exchanges/day following their physician's prescription on glucose concentration to be used. Evaluation on patient satisfaction will be done with a questionnaire at three times: before switch to twist, after two weeks on twist and at four weeks on tested products (end of study).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient satisfaction on handling by comparing current system with new system, twist.

Secondary outcome measures

Collect safety data on new patient line.

Overall trial start date

22/01/2007

Overall trial end date

10/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from chronic renal failure
2. Age 18 years or older
3. Treated in a Continuous Ambulatory Peritoneal Dialysis (CAPD) program with Gambrosol trio (GEM 20U03 Ca 2,5)
4. Treated on CAPD for at least 24 months
5. Signed written informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

5

Participant exclusion criteria

1. Pregnancy
2. HIV
3. Hepatitis
4. Participation in other studies during the study period if considered to cause interference with either of the studies
5. Treated in a haemodialysis program, patients with diagnosed abdominal pain not related with PD solution
6. Patients on night Automated Peritoneal Dialysis (APD)
7. Peritonitis within one month prior to the study
8. Presence of exit-site/tunnel infection or ongoing peritonitis
9. Impaired and /or disabled patients

Recruitment start date

22/01/2007

Recruitment end date

10/03/2007

Locations

Countries of recruitment

Italy

Trial participating centre

Gambro
Mölndal
SE-431 37
Sweden

Sponsor information

Organisation

Gambro (Sweden)

Sponsor details

Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
SE 220 10
Sweden

Sponsor type

Industry

Website

http://www.gambro.com/start.aspx?id=752

Funders

Funder type

Industry

Funder name

Gambro (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes