medical device pivotal clinical study to assess the anti-adhesive effect and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine

A randomized, multi-center, evaluator and subject blind, active-controlled, parallel, medical device pivotal clinical study to assess the anti-adhesive effect and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002393

Enrollment

192

Registered

2017-07-28

Start date

2017-03-02

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : after hysteroscopic surgery, the study gel up to 10mL was applied into the uterine cavity in both group

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
rate of adhesion formation by an independent investigator	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactSung-hoon Kim

Asan Medical Center

Outcome results