Clinical trial · Interventional
Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
NCT06229080CI-TRIAL-00103123SEGWAYcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer (Primary and Metastatic) | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NexGel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Test group
- description
- short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver.
- interventionNames
- Device: NexGel
Primary outcomes (1)
- measure
- Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
- timeFrame
- Day 1, The day after radioembolization
- description
- Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
Secondary outcomes (6)
- measure
- Angiographic recanalization of the transiently embolized hepatic arteries
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 19 years or older 2. Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings 3. Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization 4. Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year 5. Child-Pugh class A 6. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower 7. Patients whose treatment area, as determined by planning angiography, includes at least two liver segments 8. Patients for whom normal liver tissue constitutes 50% or more of the treatment volume Exclusion Criteria: 1. Liver cancer with vascular invasion 2. For primary liver cancer, patients who have been diagnosed with a malignancy other than the primary liver cancer within 2 years prior to study enrollment 3. Patients who have undergone biliary-enteric anastomosis 4. Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging 5. Patients with a known contraindication to gelatin use
References
Publications (0)
Data not yet available
No reference posted for this study.