Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL fo... | NCT02097446

Studies
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy

NCT02097446

Sponsor

Genewel Co., Ltd

Status

Unknown status

Last Update Posted

Mar 27, 2014Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Genital Diseases, Female

Interventions

Guardix-FL
Interceed

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Mar 21, 2014

First Submission Date that Met QC Criteria

Mar 24, 2014

First Posted Date

Mar 27, 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

Mar 24, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
Primary Outcome Measure : Anti-adhesion Rate
Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GUARDIX-FL	Experimental	Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day).	Device: Guardix-FL
Interceed	Active Comparator	Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).	Device: Interceed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guardix-FL	Device		GUARDIX-FL
Interceed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Adhesion Rate	Adhesion yes or no	Post-Operative Day+4weeks(Second - look)

Secondary Outcomes

Measure	Description	Time Frame
Score	Length of Adhesion x Grade of Adhesion	Post-Operative Day+4weeks(Second-look)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who sign the written informed consent
Women aged between 18 and 44
The patients who are able to participate in clinical trial during the period of study
The patients without abnormal figures at the screening laboratory examination
The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)

Exclusion Criteria:

The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
The patients with severe drug allergy
The patients with infectious disease on abdominal or pelvic cavity
The patients who previously participated in another clinical trials within the past 30 days
The patients considered inappropriate for the study
The pregnant
The patients with severe renal disease
The patients with severe systemic diseases

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Ho Kim, Master	Contact	82-10-6455-3455		junho1012@idongsung.com
Dan Bee Youn, Bachelor's	Contact	82-10-5061-3675		yzz3675@idongsung.com

Overall Officials

Name	Affiliation	Role
Joong Sub Choi, Ph.D	Hanyang University Seoul Hospital	Study Director
Seong Hun Kim, Ph.D	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Seoul Hospital		Seoul	Seoul	133-792	South Korea

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

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Browse Branches

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