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

March 24, 2014 updated by: Genewel Co., Ltd

Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study

  • 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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GUARDIX-FL
Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day).
Device: Guardix-FL
Active Comparator: Interceed
Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).
Device: Interceed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genewel Co., Ltd

Investigators

  • Study Director: Joong Sub Choi, Ph.D, Hanyang University Seoul Hospital
  • Principal Investigator: Seong Hun Kim, Ph.D, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Genewel1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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