Hydrogel Injection to Assist Endoscopic Submucosal Dissection

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-08-20

Brief Summary

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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.

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Detailed Description

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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/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps.

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

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".

Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.

Conditions

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Submucosal Tumor of Gastrointestinal Tract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic submucosal dissection

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

Group Type EXPERIMENTAL

sodium alginate mixed with calcium lactate

Intervention Type DEVICE

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".

Interventions

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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".

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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 Criteria

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).

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No