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

NCT02097446 | Unknown Phase 3 DMC

• 1 other identifier: Genewel1301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Genital Diseases, Female

Keywords

cystectomy

Outcome Measures

Primary Outcomes (1)

• Anti-Adhesion Rate

  Adhesion yes or no

  Post-Operative Day+4weeks(Second - look)

Secondary Outcomes (1)

• Score

  Post-Operative Day+4weeks(Second-look)

Study Arms (2)

GUARDIX-FL

EXPERIMENTAL

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

Device: Guardix-FL

Interceed

ACTIVE COMPARATOR

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

Device: Interceed

Interventions

Guardix-FL DEVICE

GUARDIX-FL

Interceed DEVICE

Interceed

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patients who sign the written informed consent
• Women aged between 18 and 44
• The patients who are able to participate in clinical trial during the period of study
• The patients without abnormal figures at the screening laboratory examination
• The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)

You may not qualify if:

• The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
• The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
• The patients with severe drug allergy
• The patients with infectious disease on abdominal or pelvic cavity
• The patients who previously participated in another clinical trials within the past 30 days
• The patients considered inappropriate for the study
• The pregnant
• The patients with severe renal disease
• The patients with severe systemic diseases

Sponsors & Collaborators

• Genewel Co., Ltd: lead

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, Seoul, 133-792, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Joong Sub Choi, Ph.D

  Hanyang University Seoul Hospital

  STUDY DIRECTOR

• Seong Hun Kim, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ho Kim, Master

CONTACT

82-10-6455-3455; junho1012@idongsung.com

Dan Bee Youn, Bachelor's

CONTACT

82-10-5061-3675; yzz3675@idongsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 27, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

KR (1)