Genital Diseases, Female
Conditions
Keywords
cystectomy
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)
Interventions
DEVICEGuardix-FL
DEVICEInterceed
Sponsors
Genewel Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Adhesion Rate | Post-Operative Day+4weeks(Second - look) | Adhesion yes or no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score | Post-Operative Day+4weeks(Second-look) | Length of Adhesion x Grade of Adhesion |
Countries
South Korea
Contacts
Primary ContactJun Ho Kim, Master
Backup ContactDan Bee Youn, Bachelor's
Outcome results
None listed