CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
sodium alginate mixed with calcium lactatedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03321396
NCT03321396N/ACompleted
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Gut Guarding Gel for Endoscopic Resection to Treat Early Gastroenterological Tumor and Polyps (Evaluation of the Safety of Sodium Alginate Mixed With Calcium Lactate on Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection)

National Cheng-Kung University Hospital·interventional·Posted Oct 25, 2017·Updated Nov 27, 2019

In Brief

A clinical study evaluating sodium alginate mixed with calcium lactate for Submucosal Tumor of Gastrointestinal Tract. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubmucosal Tumor of Gastrointestinal Tract
CountriesTaiwan
CollaboratorsThe Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartSep 1, 2017
Primary CompletionAug 20, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.7 years ago

Interventions

sodium alginate mixed with calcium lactatedevice

The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".