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NCT03913507: MACRODUCT-3710
Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
NA trial testing Macroduct® Advanced Model 3710 SYS, Wescor in Cystic Fibrosis in 57 participants. Completed in 22 March 2021.
31 December 2020
Quick facts
| Lead sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 57 |
| Start date | 14 July 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 22 March 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Macroduct® Advanced Model 3710 SYS, Wescor
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain — full company profile →
Who can join
Adults 2 Days to 12 Months, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03913507
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting
Other Cliniques universitaires Saint-Luc- Université Catholique de Louvain trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03913507 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Last refreshed: 24 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03913507.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing