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

Genital Diseases, Female Clinical Trial

— GUARDIX-FL  

Official title:

Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02097446
• Other study ID #: Genewel1301
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 21, 2014
• Last updated: March 24, 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2014
• Source: Genewel Co., Ltd
• Contact: Jun Ho Kim, Master
• Phone: 82-10-6455-3455
• Email: junho1012[@]idongsung.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Genital Diseases, Female

Intervention

Device:
• Guardix-FL

• Interceed

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genewel Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Adhesion Rate	Adhesion yes or no	Post-Operative Day+4weeks(Second - look)	No
Secondary	Score	Length of Adhesion x Grade of Adhesion	Post-Operative Day+4weeks(Second-look)	No