EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01735786

Enrollment

164

Registered

2012-11-28

Start date

2010-04-30

Completion date

2012-03-31

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps, Endoscopic Hemostasis

Keywords

Endoscopic Hemostasis, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps

Brief summary

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.

Interventions

DEVICEEndoClot

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Rebleeding rate after EMR procedure	up to 1 week	Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin \> 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.

Secondary

Measure	Time frame	Description
Mucosal healing after EMR	up to 1 month	Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
gastrointestinal tract obstruction	up to 1 month	Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026