Clinical trial · Observational
Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort
Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.
NCT03611504CI-TRIAL-00037204completedClinicalTrials.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)
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Besides, we aim to detect predictors of treatment failure defined as unsuccessful immediate hemostasis or rebleeding.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Hemorrhage | — | UNRESOLVED | — |
| Tumor Bleeding | — | UNRESOLVED | — |
| Ulcer Hemorrhage | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemospray® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hemospray® group
- description
- Patients with gastrointestinal bleeding treated with Hemospray®.
- interventionNames
- Device: Hemospray®
Primary outcomes (2)
- measure
- Hemospray® intraprocedural bleeding control
- timeFrame
- From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1.
- description
- It refers to the proportion (%) of patients who achieves intraprocedural hemostasis with Hemospray®. Intraprocedural bleeding control is defined as endoscopic observation of bleeding cessation after Hemospray® use.
- measure
- Rebleeding rate
- timeFrame
- Date of Hemospray® application until rebleeding, assessed up to 48 months
- description
- To describe the rebleeding rate (%) after Hemospray®. Rebleeding is defined as a new episode of hematemesis, rectorrhagia or melena; hemoglobin level decrease \>2 g/dL within 48 h of the index endoscopy or direct visualization of active bleeding at the previously treated lesion at repeat endoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with gastrointestinal bleeding treated with Hemospray®. Exclusion Criteria: * None.
References
Publications (0)
Data not yet available
No reference posted for this study.