- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097446
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 Contact
- Name: Jun Ho Kim, Master
- Phone Number: 82-10-6455-3455
- Email: junho1012@idongsung.com
Study Contact Backup
- Name: Dan Bee Youn, Bachelor's
- Phone Number: 82-10-5061-3675
- Email: yzz3675@idongsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 133-792
- Hanyang University Seoul Hospital
-
Contact:
- Hae Jeong Kim, Bachelor's
- Phone Number: 82-10-2987-0960
- Email: lovejunjung@hanmail.net
-
-
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
16 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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).
|
|
Active Comparator: Interceed
Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).
|
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
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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