Trials / Unknown
UnknownNCT02097446
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy
Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Genewel Co., Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 44 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Guardix-FL | |
| DEVICE | Interceed |
Timeline
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2014-03-27
- Last updated
- 2014-03-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02097446. Inclusion in this directory is not an endorsement.