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

Genewel

Status and phase: Unknown; Phase 3

Conditions: Genital Diseases, Female

Treatments: Device: Guardix-FL; Device: Interceed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097446

Genewel1301

Details and patient eligibility

About

• 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)

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

GUARDIX-FL

Experimental group

Description:

Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day).

Treatment:

Device: Guardix-FL

Interceed

Active Comparator group

Description:

Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).

Treatment:

Device: Interceed