To Evaluate Anti-adhesive Effect and Safety of a Mixed So... | NCT02957500

Studies
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

NCT02957500

Sponsor

CGBio Inc.

Status

Unknown status

Last Update Posted

Mar 28, 2017Actual

Enrollment

198Estimated

Phase

Not Applicable

Conditions

Gynecologic Disease

Interventions

Mediclore® (adhesion barrier)

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 2016

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

Nov 22, 2016Actual

Primary Completion Date

Jun 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Nov 3, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 7, 2016Estimated

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

Mar 26, 2017

Last Update Posted Date

Mar 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

Detailed Description

to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier

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

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mediclore®	Experimental	adhesion barrier Mediclore 5cc, to apply medical device fully around intrauterine surgery area	Device: Mediclore® (adhesion barrier)
No treatment	No Intervention	standard treatment for surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mediclore® (adhesion barrier)	Device		Mediclore®

Measure	Description	Time Frame
Adhesion incidence rate following 4 weeks		4weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
Written informed consent
Patients without clinically significant lab

Exclusion Criteria:

having enrolled another clinical trials within 1 month
Immunosuppression or autoimmune disease
Anticoagulant, general steroids within a week from surgery
Incompatible medications
Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jihee Jang	Contact	+82-2-550-8037		jhchang@daewoong.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHA kangnam medical center, CHA university	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005831	Genital Diseases, Female

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided