None listed
Conditions
Interventions
Medical Device : This study is proceeded with patients who are scheduled to have intrauterine surgery because of their gynecological diseases. Patients who completed the consent form and screening eva
Sponsors
Dalim Tissen
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female at least 19 years old 2. Patients scheduled for intrauterine surgery because of the following gynecological diseases - Submucosal myoma - Endometrial polyp - Uterine septa - Endometrial hyperplasia - Intrauterine adhesion - Abnormal uterine bleeding 3. Patients who are willing to voluntarily participate in the trial and are willing to follow the protocol
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, a target subject can not be enrolled. ? Pregnant, lactating women, and women having a pregnancy plan during the clinical trial ? Patients who intend to use an intrauterine device for contraception during the clinical trial ? Patients who need hormone therapy after intrauterine surgery ? Patients who had GnRH hormone therapy within 3 months before screening ? Patients who have local or systemic infection, endometrial cancer (uterus and endometrium, cervical cancer) and excessive uterine bleeding ? Patients who have abnormal liver function, abnormal kidney function, abnormal hemostatic function ? Patients who are applied anti-coagulants or who took systemic steroids within 1 week before surgical operation ? Patients with immunosuppression or autoimmune diseases ? Patients with uncontrolled diabetes ? Patients with hypersensitivity to the medical device for clinical trials ? Patients who have participated in other clinical trials within 30 days prior to participating in this clinical trial ? In the case that investigators made a decision that a person is inappropriate to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the adhesion incidence rate;All adverse events that occurred to the subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| the mean score of adhesion type;the mean score of adhesion extent | — |
Countries
Korea, Republic of
Contacts
Public ContactSunghoon Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed