Surgicel® (Fibrillar) in Non-variceal UGI Bleeding | NCT02054260

Studies
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding

NCT02054260

Sponsor

Soonchunhyang University Hospital

Status

Unknown status

Last Update Posted

Nov 19, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Non-variceal Upper Gastrointestinal Bleeding

Interventions

Surgicel

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Feb 3, 2014

First Submission Date that Met QC Criteria

Feb 3, 2014

First Posted Date

Feb 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Description Module

Brief Summary

The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Surgicel add therapy	Experimental		Drug: Surgicel

Name	Type	Description	Arm Group Labels	Other Names
Surgicel	Drug		Surgicel add therapy

Measure	Description	Time Frame
Rebleeding rate at the second look endoscopy		2 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
Patients with active bleeding (Forrest classification Ia or Ib or IIa)

Exclusion Criteria:

Patients with upper gastrointestinal tract malignancy
Patients with acute severe illness
Coagulopathy: liver cirrhosis, thrombocytopenia
Pregnant women

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Su Jin Hong, MD, PhD	Contact	+82-32-621-5087		sjhong@schmc.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine	Recruiting	Bucheon-si		420-767	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C013695	Surgicel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided