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

Genital Diseases, Female Clinical Trial

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

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02097446
Study type Interventional
Source Genewel Co., Ltd
Contact Jun Ho Kim, Master
Phone 82-10-6455-3455
Email junho1012@idongsung.com
Status Not yet recruiting
Phase Phase 3
Completion date January 2015
View Details
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