Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-02 @ 9:24 AM
Study NCT ID:
NCT07131293
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Registry Study on Lymphatic Interventions
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EURO-LYMPH
Brief Summary:
This European multicenter observational study aims to evaluate the real-world use, timing, and outcomes of lymphatic interventions in patients with congenital heart disease and/or primary lymphatic disorders. The study will examine the effectiveness of diagnostic imaging and interventional techniques, such as lymphatic embolization, in improving clinical symptoms, biomarkers, and fluid-related complications. The central question is whether early diagnosis and targeted intervention can lead to clinically meaningful improvements and reduced need for reintervention. Data collected retrospectively and prospectively from participating centers will help identify predictors of outcome, assess disease severity, and inform standardized diagnostic and therapeutic pathways across Europe.
Detailed Description:
This is a prospective, multicenter observational study with retrospective components. The study population includes patients who have undergone or are undergoing lymphatic imaging diagnostics and lymphatic interventions at participating centers across Europe. Patients are included both retrospectively (from medical records) and prospectively as part of their routine clinical care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: