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EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

NCT ID: NCT01735786

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-03-31

Brief Summary

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Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.

Detailed Description

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Conditions

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Endoscopic Hemostasis Colonic Polyps

Keywords

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Endoscopic Hemostasis EndoClot Absorbable Polysaccharide Hemostat Colonic Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Treatment group

Subjects in this group will received Endoclot treatment immediately after EMR.

EndoClot

Intervention Type DEVICE

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Control group

Subjects in this group will not received any hemostasis treatment after EMR.

No interventions assigned to this group

Interventions

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EndoClot

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.

Exclusion Criteria

* severe cardiovascular diseases, liver and kidney dysfunction;
* platelet and coagulation dysfunction (PLT \< 50\*109/L, INR \> 2);
* cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
* cases unavailable for follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Zhiguo Liu

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiguo Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032

Locations

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Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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20121125

Identifier Type: -

Identifier Source: org_study_id