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TRAP Intervention STudy: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence
NCT02621645 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02621645 reports 14 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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