Status:
COMPLETED
Hydrogel Injection to Assist Endoscopic Submucosal Dissection
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
The Industrial Technology Research Institute
National Cheng Kung University
Conditions:
Submucosal Tumor of Gastrointestinal Tract
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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/En...
Detailed Description
The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endosc...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria in order to be entered into the study:
- A. Both genders of patients age 20 or older.
- B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis.
- C. Tumor or polyps ≧ 20 millimeters.
- D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment.
- E. No evidence of depth of submucosal invasion or metastasis via endoscopy.
Exclusion
- If patients meet any of the following criteria they may not be entered into the study:
- A. Patients suffering from other advanced malignant tumors.
- B. White Blood Cell\< 2000 μL or Severe thrombocytopenia（Platelet count \< 50,000 μL)，or blood coagulation abnormalities uncorrectable .
- C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration.
- D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
- E. Evidence of depth of submucosal invasion or metastasis via endoscopy.
- F. Unable to follow-up by endoscopy.
- G. Unwilling to sign informed consent.
- H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03321396
Start Date
September 1 2017
End Date
August 20 2018
Last Update
November 27 2019
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan