Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT01840033 |
Date of registration:
|
23/04/2013 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used.
PICCNUT |
Scientific title:
|
A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used: the PICCnut Study. |
Date of first enrolment:
|
April 2013 |
Target sample size:
|
7 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT01840033 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
France
| | | | | | | |
Contacts
|
Name:
|
HEBUTERNE Xavier, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
CHU de Nice, Hôpital Archet, Pôle Digestif, 151 route de saint-antoine de ginestière 06200 Nice |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- > 18 years-old
- Patients managed by CHU Nice for home parenteral nutrition
- Expected to have over 1 month of parenteral nutrition
- Signed consent
- Affiliation to Securite Social
Exclusion criteria
- Patient with nutritional catheter before inclusion
- Pregnancy or breastfeeding
- Evolutive pathology with life expectancy < 12 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Chronic Intestinal Failure
|
Intervention(s)
|
Device: Tunnelled nutritional central catheter
|
Device: group Piccnut
|
Primary Outcome(s)
|
major complications
[Time Frame: 12 months]
|
Secondary Outcome(s)
|
Questionnaire
[Time Frame: 12 months]
|
Delay
[Time Frame: 12 months]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|