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Hydrogel Injection to Assist Endoscopic Submucosal Dissection

NCT03321396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-11-27

Study results available
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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.

Conditions

  • Submucosal Tumor of Gastrointestinal Tract

Interventions

DEVICE

sodium alginate mixed with calcium lactate

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".

Sponsors & Collaborators

  • The Industrial Technology Research Institute

    collaborator OTHER

  • National Cheng Kung University

    collaborator OTHER

  • National Research Program for Biopharmaceuticals, Taiwan

    collaborator OTHER

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Jui-Wen Kang · Department of Internal Medicine, National Cheng Kung University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-08-20
Completion
2018-08-20

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03321396 on ClinicalTrials.gov