Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077981
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-09-27
Brief Title:
Comparison of 04 Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Instituto do Cancer do Estado de São Paulo
Study Overview
Official Title:
Comparison of 04 Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
1 Design of the study
This is a randomized clinical trial in a single center The lesions will be randomized into three blocks based on the diameter of the largest axis less than 3 cm between 3 - 5 cm and greater than 5 cm
2 Selection of patients
The population studied will be patients with early esophageal neoplasia diagnosed andor referred for submucosal endoscopic dissection at the São Paulo Cancer Institute ICESP University of São Paulo
3 Evaluation of effectiveness and definitions
Effectiveness will be measured from the degree of usefulness The degree of utility will be determined from two variables obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection The solution that results in a complete block resection with a number of additional injections of 0 excellent utility degree or 1 good utility degree will be considered effective
This is a randomized clinical trial in a single center The lesions will be randomized into three blocks based on the diameter of the largest axis less than 3 cm between 3 - 5 cm and greater than 5 cm
2 Selection of patients
The population studied will be patients with early esophageal neoplasia diagnosed andor referred for submucosal endoscopic dissection at the São Paulo Cancer Institute ICESP University of São Paulo
3 Evaluation of effectiveness and definitions
Effectiveness will be measured from the degree of usefulness The degree of utility will be determined from two variables obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection The solution that results in a complete block resection with a number of additional injections of 0 excellent utility degree or 1 good utility degree will be considered effective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None