Clinical trial · Interventional
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
- 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 a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).
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 |
|---|---|---|---|
| Endoscopic Mucosal Resection | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hyaluronic Acid | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) | Procedure | — | UNRESOLVED |
| Submucous Endoscopic Dissection with hydroxyethylamide | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hydroxyethylamide Group
- description
- 15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide.
- interventionNames
- Procedure: Submucous Endoscopic Dissection with hydroxyethylamide
- type
- ACTIVE_COMPARATOR
- label
- Hyaluronic acid group (TS-905 Blue Eye)
- description
- 15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed.
- interventionNames
- Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age * Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of ESD after discussion in a multidisciplinary oncological board * Signed informed consent form Exclusion Criteria: * Residual or recurrent esophageal lesions * Ulcerated esophageal lesions * Patients with severe cardiovascular, kidney or liver disease * History of hypersensitivity to hyaluronic acid * Pregnant or lactating women
References
Publications (0)
Data not yet available