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

G

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

Trial contacts and locations

1

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Central trial contact

Jun Ho Kim, Master; Dan Bee Youn, Bachelor's

Data sourced from clinicaltrials.gov

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