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EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

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Xijing Hospital of Digestive Diseases

Status

Completed

Conditions

Colonic Polyps
Endoscopic Hemostasis

Treatments

Device: EndoClot

Study type

Observational

Funder types

Other

Identifiers

NCT01735786
20121125

Details and patient eligibility

About

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.

Enrollment

164 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

164 participants in 2 patient groups

Treatment group
Description:
Subjects in this group will received Endoclot treatment immediately after EMR.
Treatment:
Device: EndoClot
Control group
Description:
Subjects in this group will not received any hemostasis treatment after EMR.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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