medical device pivotal clinical study to assess the anti-adhesive effect and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0002393
- Lead Sponsor
- Medytox
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 192
1. female between 19 and 69 years of age
2. Patients diagnosed with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding who will undergo hysteroscopy
3. Given written informed consent
1. women who planned to use an intra-uterine divice(IUD) or Foley catherter
2.hormone therapy after hysteroscopic surgery
3.Stricture and stenosis of cervix uteri, uterine prolapse, pelvic inflammatory disease, cancer, heavy uterine bleeding, cervical infection
4.local or systemic infection
5.immunosuppression or auto immune disease
6.hyperlipidemia
7. anticoagulants treatment within a week before the operation day
8. allergies to the study materials
9. women who were pregnant or who planned pregnancy during the study period
10. Investigator's opinion that the subject has a concurrent condition that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
11.women live with alcohol or drug abuse
12.women who have been involved in other clinical studies
13.women who the investigators decided not to enroll in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of adhesion formation by an independent investigator
- Secondary Outcome Measures
Name Time Method the sum of extent of adhesion and the adhesion score were evaluated by an independent investigator;extent of adhesion score were evaluated by an independent investigator;adhesion score were evaluated by an independent investigator;rate of adhesion formation by an investigator;the sum of extent of adhesion and the adhesion score were evaluated by an investigator;extent of adhesion score were evaluated by an investigator;adhesion score were evaluated by an investigator