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NCT02621645 · ClinicalTrials.gov registry record · Phase 4
TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
A Phase 4 study of Twin Reversal Arterial Perfusion Syndrome, sponsored by Universitaire Ziekenhuizen KU Leuven.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 126
- Enrollment target
- 14
- Study locations
NCT02621645 is a Phase 4 study of Twin Reversal Arterial Perfusion Syndrome that is actively recruiting participants, run by Universitaire Ziekenhuizen KU Leuven. The registered enrollment target is 126 participants. The trial reports 14 study locations across 2 states.
The verdict
NCT02621645, a Phase 4 study of Twin Reversal Arterial Perfusion Syndrome, is actively recruiting participants, sponsored by Universitaire Ziekenhuizen KU Leuven.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 126 participants
- Enrollment target
- 14
- Study locations
Study Summary
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.
Conditions Studied
Interventions
- PROCEDURE Early selective reduction of TRAP mass
- PROCEDURE Late selective reduction of TRAP mass
- DEVICE Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle
- DEVICE Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle
- DEVICE Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber
Study Locations (14)
Other
- Universitätsklinik für Frauenheilkunde und Geburtshilfe - Graz
- Universitaire Ziekenhuizen Leuven - Leuven
- Mount Sinai Hospital - Toronto
- Centre Médico-Chirurgical et Obstétrical - Schiltigheim
- Universitätsklinikum Hamburg-Eppendorf - Hamburg
- Sheba Medical Center - Tel Litwinsky
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico - Milan
- Ospedale dei Bambini Vittore Buzzi - Milan
- Leiden University Medical Center - Leiden
- Hospital Universitari Vall d'Hebron - Barcelona
- Birmingham Women's Hospital - Birmingham
- King's College - London
- St. George's Hospital, University of London (UK sponsor) - London
Texas
- Children's Memorial Hermann Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2016-05 |
| Est. Completion | 2025-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02621645
The ClinicalTrials.gov registry entry for NCT02621645 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Universitaire Ziekenhuizen KU Leuven, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Twin Reversal Arterial Perfusion Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Early selective reduction of TRAP mass is the first listed.
NCT02621645 reports 14 study locations spanning 2 distinct geographic areas - top geographies include Other, Texas.
Frequently Asked Questions
What is clinical trial NCT02621645 about?
NCT02621645 is a clinical study titled "TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence". Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diag...
What is the current status of trial NCT02621645?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 126 participants. The study started on 2016-05. Estimated completion is 2025-06.
What conditions does trial NCT02621645 study?
This clinical trial studies the following conditions: Twin Reversal Arterial Perfusion Syndrome.
What interventions are being tested in trial NCT02621645?
The interventions under investigation include: Early selective reduction of TRAP mass (PROCEDURE), Late selective reduction of TRAP mass (PROCEDURE), Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle (DEVICE), Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle (DEVICE), Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber (DEVICE).
Who is sponsoring clinical trial NCT02621645?
This trial is sponsored by Universitaire Ziekenhuizen KU Leuven, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02621645 being conducted?
This trial has 14 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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