Actively Recruiting
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-01
30
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of endoscopic submucosal dissection after multidisciplinary oncological board review
- Signed informed consent form
You will not qualify if you...
- Residual or recurrent esophageal lesions
- Ulcerated esophageal lesions
- Severe cardiovascular, kidney, or liver disease
- History of hypersensitivity to hyaluronic acid
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
Research Team
F
Fauze Maluf-Filho, PhD
CONTACT
P
Pierre Pirchner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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