Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis (MACRODUCT-3710)
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|ClinicalTrials.gov Identifier: NCT03913507|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.
In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Macroduct® Advanced Model 3710 SYS, Wescor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis|
|Actual Study Start Date :||July 14, 2018|
|Estimated Primary Completion Date :||July 14, 2020|
|Estimated Study Completion Date :||July 14, 2020|
|Experimental: one group : patients with suspicion of cystic fibrosis||
Device: Macroduct® Advanced Model 3710 SYS, Wescor
for each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine.
- chloride concentration [ Time Frame: day 1 ]The volume and the chloride concentration will be analyzed for each subject.
- sweat [ Time Frame: day 1 ]
sweat collected with sweat collection method (Macroduct® Advanced) Model 3710 SYS, Wescor) compared with that currently used in clinical routine.
The effectiveness criterion of the new Macroduct Advanced collector will be defined as follows: the new device tested will be considered effective if the insufficient amount of sweat levels obtained are smaller or equal to those recommended, i.e. if it is lower than 10% in children under 3 months and below 5% in children between 3 and 12 months.
The insufficient amount of sweat rates will be compared between the two methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913507
|Contact: Teresinha Teresinha||00 32 2 764 9473 ext email@example.com|
|Contact: Audrey REYNAERTS||00 32 2 764 9472 ext firstname.lastname@example.org|
|Cliniques Universitaires St Luc||Recruiting|
|Brussels, Belgium, 1200|
|Principal Investigator:||Teresinha Leal||Cliniques universitaires Saint-Luc- Université Catholique de Louvain|