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

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ClinicalTrials.gov Identifier: NCT02097446
Recruitment Status : Unknown
Verified March 2014 by Genewel Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2014
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Genewel Co., Ltd

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)

Condition or disease Intervention/treatment Phase
Genital Diseases, Female Device: Guardix-FL Device: Interceed Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: GUARDIX-FL
Patients will be treated with 1 or 2 sheet of GUARDIX-FL after ovarian cystectomy(Operative Day).
Device: Guardix-FL
Active Comparator: Interceed
Patients will be treated with 1 or 2 sheet of interceed after ovarian cystectomy(Operative Day).
Device: Interceed



Primary Outcome Measures :
  1. Anti-Adhesion Rate [ Time Frame: Post-Operative Day+4weeks(Second - look) ]
    Adhesion yes or no


Secondary Outcome Measures :
  1. Score [ Time Frame: Post-Operative Day+4weeks(Second-look) ]
    Length of Adhesion x Grade of Adhesion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097446


Contacts
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Contact: Jun Ho Kim, Master 82-10-6455-3455 junho1012@idongsung.com
Contact: Dan Bee Youn, Bachelor's 82-10-5061-3675 yzz3675@idongsung.com

Locations
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Korea, Republic of
Hanyang University Seoul Hospital Not yet recruiting
Seoul, Korea, Republic of, 133-792
Contact: Hae Jeong Kim, Bachelor's    82-10-2987-0960    lovejunjung@hanmail.net   
Sponsors and Collaborators
Genewel Co., Ltd
Investigators
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Study Director: Joong Sub Choi, Ph.D Hanyang University Seoul Hospital
Principal Investigator: Seong Hun Kim, Ph.D Severance Hospital

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Responsible Party: Genewel Co., Ltd
ClinicalTrials.gov Identifier: NCT02097446     History of Changes
Other Study ID Numbers: Genewel1301
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014
Keywords provided by Genewel Co., Ltd:
cystectomy
Additional relevant MeSH terms:
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Genital Diseases, Female